ELUVIA™ H74939294601210Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 08714729876618), received between May 10, 2019 and Jul 14, 2026 — classified as 1 death, 62 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED. ON (B)(6) 2021, AS PART OF THE CLINICAL TRIAL, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENTS. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 360 MM LESION LENGTH AND 100% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, LITHOTRIPSY WAS PERFORMED USING 5 MM X 60 MM SHOCKWAVE DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM, 3 MM X 220 MM COYOTE OTW PTA BALLOONS AND 3.5 MM X 120 MM SERRANATOR CUTTING BALLOON. THE TREATMENT OF STENOSIS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WAS PERFORMED BY DILATION USING 5 MM X 150 MM RANGER DRUG-COATED BALLOON, STUDY DEVICE. FOLLOWING WHICH 6 MM X 120 MM, 6 MM X 100 MM ELUVIA DRUG-ELUTING STENTS, STUDY DEVICE WAS PLACED IN T

  Patient problems: Obstruction/Occlusion

  MAUDE report 25818484 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERFORATION AND FISTULA OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON AND ELUVIA DRUG-ELUTING STENTS ON (B)(6) 2021 AS PART OF THE CLINICAL TRIAL. TARGET LESION #001 WAS LOCATED IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT DISTAL SFA, AND RIGHT MID POPLITEAL ARTERY, WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM, A DISTAL REFERENCE VESSEL DIAMETER OF 5 MM, A LESION LENGTH OF 240 MM, AND 90% STENOSIS. THE LESION WAS CLASSIFIED AS A TASC II B LESION. PRIOR TO TREATMENT OF THE TARGET LESION, BALLOON DILATION WAS PERFORMED USING 4 MM X 100 MM AND 4 MM X 80 MM STERLING OTW PTA BALLOONS. TREATMENT CONSISTED OF DILATION WITH A 5 MM X 40 MM RANGER DRUG-COATED BALLOON STUDY DEVICE, FOLLOWED BY PLACEMENT OF 6 MM X 120 MM AND 6 MM X 80 MM ELUVIA DRUG-ELUTING STENT STUDY DEVICES. POST-TREATMENT DILATION WAS PERFORMED USING A 6 MM X 100 MM MUSTANG OTW PTA BALLOON, AND THE FINAL RESIDUAL STENOSIS WAS DOCUMENTED AS 0%. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. PER BASELINE CORE LAB FORM DATED (B)(6) 2021, DURING THE INDEX PROCEDURE FOR TREATMENT OF TARGET LESION #001, POST-STUDY DE

  Patient problems: Fistula; Perforation of Vessels

  MAUDE report 23839684 ↗
• InjurySep 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN STENT OCCLUSION OF THE RIGHT POPLITEAL ARTERY OCCURRED REQUIRING ADDITIONAL INTERVENTION. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH THIS ELUVIA DRUG ELUTING STENT AS A PART OF A CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE RIGHT PROXIMAL POPLITEAL ARTERY EXTENDING UP TO THE RIGHT MID POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 120 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 5.0 MM X 100 MM R2P CROSSTELLA RX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. A DISSECTION OF GRADE D WAS NOTED IN THE RIGHT PROXIMAL AND MID POPLITEAL ARTERY POST DILATION OF 5.0 MM X 100 MM R2P CROSSTELLA PTA BALLOON, WHICH WAS TREATED BY PLACEMENT OF 6 MM X 120 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING POST-DILATION USING 5.0 MM X 100 MM R2P CROSSTELLA PTA BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. POST TREATMENT, THE DISSECTION WAS RESOLVED. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN AND OTHER ANTICOAGULANT MEDICATI

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 23125281 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOTIC RE-OCCLUSION OCCURRED, REQUIRING AN ADDITIONAL DEVICE. ON (B)(6) 2023 THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG-COATED BALLOON AND ELUVIA DRUG-ELUTING STENTS AS A PART OF A CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT COMMON FEMORAL ARTERY AND LEFT DEEP FEMORAL ARTERY WITH 6.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH 50 MM LESION LENGTH WITH 65 % STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 7 MM X 80 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING PROCEDURE POST DILATION WAS PERFORMED USING 7 MM X 20 MM CUTTING BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20 %. THE TARGET LESION #002 WAS IN THE LEFT OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT PROXIMAL SFA, LEFT MID SFA, LEFT DISTAL SFA EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 350 MM LESION LENGTH WITH 95 % STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED USING 6 MM X 60 MM SHOCKWAVE LITHOTRIPSY DEV

  Patient problems: Numbness; Pain; Restenosis; Thrombosis/Thrombus

  MAUDE report 23075425 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOTIC RE-OCCLUSION OCCURRED, REQUIRING AN ADDITIONAL DEVICE. ON (B)(6) 2023 THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG-COATED BALLOON AND ELUVIA DRUG-ELUTING STENTS AS A PART OF A CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT COMMON FEMORAL ARTERY AND LEFT DEEP FEMORAL ARTERY WITH 6.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH 50 MM LESION LENGTH WITH 65 % STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 7 MM X 80 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING PROCEDURE POST DILATION WAS PERFORMED USING 7 MM X 20 MM CUTTING BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20 %. THE TARGET LESION #002 WAS IN THE LEFT OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT PROXIMAL SFA, LEFT MID SFA, LEFT DISTAL SFA EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 350 MM LESION LENGTH WITH 95 % STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED USING 6 MM X 60 MM SHOCKWAVE LITHOTRIPSY DEV

  Patient problems: Numbness; Pain; Restenosis; Thrombosis/Thrombus

  MAUDE report 23075404 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOTIC RE-OCCLUSION OCCURRED, REQUIRING AN ADDITIONAL DEVICE. ON (B)(6) 2023 THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG-COATED BALLOON AND ELUVIA DRUG-ELUTING STENTS AS A PART OF A CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT COMMON FEMORAL ARTERY AND LEFT DEEP FEMORAL ARTERY WITH 6.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH 50 MM LESION LENGTH WITH 65 % STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 7 MM X 80 MM RANGER DRUG-COATED BALLOON STUDY DEVICE. FOLLOWING PROCEDURE POST DILATION WAS PERFORMED USING 7 MM X 20 MM CUTTING BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20 %. THE TARGET LESION #002 WAS IN THE LEFT OSTIAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT PROXIMAL SFA, LEFT MID SFA, LEFT DISTAL SFA EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 350 MM LESION LENGTH WITH 95 % STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED USING 6 MM X 60 MM SHOCKWAVE LITHOTRIPSY DEV

  Patient problems: Numbness; Pain; Restenosis; Thrombosis/Thrombus

  MAUDE report 23075381 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA STUDY THAT THE SUBJECT EXPERIENCED PERIPHERAL ARTERY DISEASE AND IN-STENT OCCLUSION RESULTING IN ADDITIONAL INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT ON (B)(6) 2025 AS A PART OF THE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 100 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. AN OCCLUSION WAS ALSO NOTED IN THE LEFT SFA AND PROXIMAL POPLITEAL ARTERY. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 60 MM COYOTE PTA BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY THE PLACEMENT OF 6 MM X 120 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING STENT PLACEMENT, POST-DILATION WAS PERFORMED USING 4 MM X 60 MM COYOTE PTA BALLOON. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2025, THE SUBJECT VISITED HOSPITAL FOR 30 DAYS FOLLOW UP AND REPORTED THAT THE SYMPTOMS REMAINED UNCHANGED AND DENIED ANY IMPROVEMENTS AFTER THE INDEX PROCEDURE

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion; Unspecified Vascular Problem

  MAUDE report 22516119 ↗
• MalfunctionJun 16, 2025Entrapment of Device; Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE. THIS 6X120, 130 CM ELUVIA SELF EXPANDING STENT WAS SELECTED FOR USE DURING A PROCEDURE TO TREAT A 70% STENOSED, MILDLY CALCIFIED, SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY LESION. DURING THE PROCEDURE, THE LESION WAS PREDILATED USING A 6MM BALLOON. AFTER THE STENT HAD BEEN PROPERLY FLUSHED AND PREPARED, DIFFICULTY WAS NOTED WHEN ADVANCING THE STENT CATHETER OVER THE NON-BOSTON SCIENTIFIC GUIDEWIRE WHEN PLACING ACROSS THE LESION. EXTRA FORCE WAS NEEDED FOR PLACEMENT, AND THE STENT WAS DEPLOYED WITHOUT ISSUE; HOWEVER, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE. THE BLUE HANDLE WAS BROKEN OFF TO MAKE IT EASIER TO WALK BACK OVER THE WIRE; HOWEVER, IT WAS STILL DIFFICULT, AND AFTER APPROXIMATELY 10MM, THE WHOLE SYSTEM BECAME STUCK ON THE WIRE. THE SYSTEM WAS REMOVED ALONG WITH THE WIRE AND LESION ACCESS WAS REGAINED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE AORTA BIFURCATION WAS VERY TORTUOUS AND MAY HAVE CAUSED SOME OF THE DIFFICULTY TO ADVANCE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214590 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MONTHS POST-IMPLANT THERE WAS SIGNIFICANT THROMBUS THAT REQUIRED AN ADDITIONAL STENT. A PROCEDURE WAS PERFORMED ON (B)(6) 2025 DUE TO ATHEROSCLEROSIS OF NATIVE ARTERIES OF EXTREMITIES WITH INTERMITTENT CLAUDICATION. CIRCUMFERENTIAL CALCIFICATION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. SIGNIFICANT DISSECTION IN THE MID/DISTAL SFA FOLLOWING ATHERECTOMY AND BALLOON ANGIOPLASTY REQUIRING PLACEMENT OF TWO 6 X 120 MM ELUVIA DRUG-ELUTING OVERLAPPING STENTS WITH EXCELLENT RESULT. ON (B)(6) 2025, AN IVUS PROCEDURE WAS PERFORMED DUE TO RIGHT LEG RESTING PAIN AND FOUND THROMBOTIC OCCLUSION OF RIGHT SFA. THE RESULTS WENT FROM 100 PERCENT STENOSIS PREINTERVENTION TO LESS THAN 20 PERCENT STENOSIS POST-INTERVENTION, BUT WITH SIGNIFICANT RESIDUAL "FLAP" IN MID-STENT TREATED WITH 6 X 150 MM ELUVIA DRUG-ELUTING STENT WITHIN THE EXISTING STENT. ADDITIONAL UNRELATED LESIONS WERE TREATED AS WELL. A 6 FRENCH CELT PERCUTANEOUS CLOSURE DEVICE DEPLOYED IN LEFT COMMON FEMORAL ACCESS SITE UPON COMPLETION RESULTING IN EXCELLENT HEMOSTASIS.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 22173326 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MONTHS POST-IMPLANT THERE WAS SIGNIFICANT THROMBUS THAT REQUIRED AN ADDITIONAL STENT. A PROCEDURE WAS PERFORMED ON (B)(6) 2025 DUE TO ATHEROSCLEROSIS OF NATIVE ARTERIES OF EXTREMITIES WITH INTERMITTENT CLAUDICATION. CIRCUMFERENTIAL CALCIFICATION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. SIGNIFICANT DISSECTION IN THE MID/DISTAL SFA FOLLOWING ATHERECTOMY AND BALLOON ANGIOPLASTY REQUIRING PLACEMENT OF TWO 6 X 120 MM ELUVIA DRUG-ELUTING OVERLAPPING STENTS WITH EXCELLENT RESULT. ON (B)(6) 2025, AN IVUS PROCEDURE WAS PERFORMED DUE TO RIGHT LEG RESTING PAIN AND FOUND THROMBOTIC OCCLUSION OF RIGHT SFA. THE RESULTS WENT FROM 100 PERCENT STENOSIS PREINTERVENTION TO LESS THAN 20 PERCENT STENOSIS POST-INTERVENTION, BUT WITH SIGNIFICANT RESIDUAL "FLAP" IN MID-STENT TREATED WITH 6 X 150 MM ELUVIA DRUG-ELUTING STENT WITHIN THE EXISTING STENT. ADDITIONAL UNRELATED LESIONS WERE TREATED AS WELL. A 6 FRENCH CELT PERCUTANEOUS CLOSURE DEVICE DEPLOYED IN LEFT COMMON FEMORAL ACCESS SITE UPON COMPLETION RESULTING IN EXCELLENT HEMOSTASIS.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 22173323 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS OCCLUSION OF THE TARGET LESION THREE MONTHS POST-TREATMENT WITH ELUVIA WHERE ADDITIONAL INTERVENTION WAS PERFORMED. THE SUBJECT UNDERWENT TREATMENT WITH ELUVIA DRUG-ELUTING STENTS ON (B)(6) 2021 AS A PART OF A CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY AND LEFT DISTAL SUPERFICIAL FEMORAL ARTERY. THE LESION WAS DESCRIBED AS 7 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 7 MM DISTAL REFERENCE VESSEL DIAMETER WITH 260 MM LESION LENGTH; 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TARGET LESION TREATMENT, PRE-DILATION WAS PERFORMED USING 4 MM X 200 MM ARMADA 18 PTA BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY THE PLACEMENT OF 6 MM X 120 MM, 6 MM X 120 MM, 7 MM X 80 MM ELUVIA DRUG-ELUTING STENTS. FOLLOWING, POST-DILATION WAS PERFORMED USING 5 MM X 150 MM, AND 6 MM X 80 MM STERLING OTW PTA BALLOONS. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL AND ASPIRIN. ON (B)(6) 2021, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. ON

  Patient problems: Obstruction/Occlusion

  MAUDE report 22136412 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS OCCLUSION OF THE TARGET LESION THREE MONTHS POST-TREATMENT WITH ELUVIA WHERE ADDITIONAL INTERVENTION WAS PERFORMED. THE SUBJECT UNDERWENT TREATMENT WITH ELUVIA DRUG-ELUTING STENTS ON (B)(6) 2021 AS A PART OF A CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY AND LEFT DISTAL SUPERFICIAL FEMORAL ARTERY. THE LESION WAS DESCRIBED AS 7 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 7 MM DISTAL REFERENCE VESSEL DIAMETER WITH 260 MM LESION LENGTH; 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TARGET LESION TREATMENT, PRE-DILATION WAS PERFORMED USING 4 MM X 200 MM ARMADA 18 PTA BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY THE PLACEMENT OF 6 MM X 120 MM, 6 MM X 120 MM, 7 MM X 80 MM ELUVIA DRUG-ELUTING STENTS. FOLLOWING, POST-DILATION WAS PERFORMED USING 5 MM X 150 MM, AND 6 MM X 80 MM STERLING OTW PTA BALLOONS. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL AND ASPIRIN. ON (B)(6) 2021, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. ON

  Patient problems: Obstruction/Occlusion

  MAUDE report 22136407 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2023 THE SUBJECT UNDERWENT TREATMENT WITH THIS 6X120, 130 CM ELUVIA STENT AS PART OF A CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA, AND LEFT DISTAL SFA, WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH 260 MM LESION LENGTH WITH 100% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II CLASS C LESION. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 3 MM X 40 MM NON-BOSTON SCIENTIFIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, AND 5 MM X 220 MM PTA BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT OF 6 MM X 150 MM, 6 MM X 120 MM AND 6 MM X 80 MM ELUVIA DRUG ELUTING STENTS, STUDY DEVICES. FOLLOWING TREATMENT WAS PERFORMED BY DILATION USING 6 MM X 220 MM PTA BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2024, THE SUBJECT VISITED THE HOSPITAL WITH COMPLAINTS OF SEVERE LEFT LEG PAIN WITH

  Patient problems: Numbness; Pain; Restenosis

  MAUDE report 22132235 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN WAS REPORTED THAT IN-STENT OCCLUSION OCCURRED. ON (B)(6) 2025, THE PATIENT UNDERWENT A SELECTIVE LEFT LOWER EXTREMITY ARTERIOGRAM. THIS SHOWED THE COMMON FEMORAL AND PROFUNDO FEMORAL TO BE WIDELY PATENT. THE SUPERFICIAL FEMORAL ARTERY WAS PATENT PROXIMALLY BUT WAS MARKEDLY NARROWED OVER APPROXIMATELY 10 OM AT WHICH POINT THE VESSEL WAS TOTALLY OCCLUDED. ARTERIOGRAM DEMONSTRATED TOTAL OCCLUSION DOWN TO THE DISTAL ABOVE-KNEE POPLITEAL ARTERY. THE PREVIOUSLY PLACED STENT THROUGH HUNTER'S CANAL WAS TOTALLY OCCLUDED AND THERE WAS RECONSTITUTION OF THE ABOVE-KNEE POPLITEAL JUST BELOW THE OCCLUDED STENT. THE ABOVE-KNEE POPLITEAL WAS DISEASED OVER APPROXIMATELY 8 CM AND ABOUT THE PATELLA BECAME NORMAL IN SIZE. THE BELOW-KNEE POPLITEAL ARTERY WAS WIDELY PATENT AND THERE WAS THROUGH-VESSEL RUNOFF PROXIMALLY INTO THE CALF. HOWEVER, THE POSTERIOR DIAL ARTERY WAS FOUND LATER TO BE TOTALLY OCCLUDED IN THE MIDCALF DISTALLY. THE PATIENT WAS GIVEN 5000 UNITS OF HEPARIN INTRAVENOUSLY AND A 6 X 45 SHEATH WAS ADVANCED TO THE LEFT COMMON FEMORAL ARTERY. USING A 0.035 GLIDEWIRE AND RUBICON CATHETER, WE WERE ABLE TO ENTER THE SUPERFICIAL FEMORAL ARTERY AND GRADUALLY ADVANCE THROUGH THE OCCLUDED STENT

  Patient problems: Obstruction/Occlusion

  MAUDE report 21960566 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2025, TWO 6X120, 130 CM ELUVIA STENTS WERE SELECTED FOR USE DURING AN ATHERECTOMY WITH ANGIOPLASTY AND STENT PLACEMENT PROCEDURE. SELECTIVE RIGHT LOWER EXTREMITY ARTERIOGRAM WAS PERFORMED WHICH SHOWED COMPLETE OCCLUSION OF THE ENTIRE SFA AND ENTIRE POPLITEAL ARTERY. THEY WERE ABLE TO PASS TO THE BELOW-KNEE POPLITEAL ARTERY, THEN A NON-BSC ATHERECTOMY DEVICE WAS USED ON THE ENTIRE LENGTH OF THE SFA AND POPLITEAL ARTERIES. REPEAT ARTERIOGRAM WAS PERFORMED, AND IT WAS NOTED THAT THE FLOW WAS QUITE SLUGGISH DUE TO DISTAL OBSTRUCTION IN THE ABOVE-KNEE POPLITEAL AND DISTAL SFA. A 5 X 220 BALLOON WAS USED ON THE POPLITEAL AND SFA. FLOW WAS STILL POOR WITH OBSTRUCTIVE DEBRIS WITHIN THE PREVIOUSLY PLACED STENTS. THEREFORE, A 6X120, 130 CM ELUVIA STENT WAS PLACED IN THE POPLITEAL ARTERY, AND A SECOND 6X120, 130 CM ELUVIA STENT WAS PLACED JUST ABOVE THE FIRST STENT, OVERLAPPING BY 1 CM. THE VESSELS WERE THEN DILATED AND FOLLOWING THIS THERE WAS GOOD FLOW BUT WITH A SIGNIFICANT DISSECTION IN THE ABOVE-KNEE POPLITEAL STENT. A 6 X 60 INNOVA STENT WAS THEN PLACED IN THE ABOVE-KNEE POPLITEAL. REPEAT ANGIOGRAM THEN SHOWED T

  Patient problems: Restenosis

  MAUDE report 21938650 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RESTENOSIS GUARANTEE PROGRAM. IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2025, TWO 6X120, 130 CM ELUVIA STENTS WERE SELECTED FOR USE DURING AN ATHERECTOMY WITH ANGIOPLASTY AND STENT PLACEMENT PROCEDURE. SELECTIVE RIGHT LOWER EXTREMITY ARTERIOGRAM WAS PERFORMED WHICH SHOWED COMPLETE OCCLUSION OF THE ENTIRE SFA AND ENTIRE POPLITEAL ARTERY. THEY WERE ABLE TO PASS TO THE BELOW-KNEE POPLITEAL ARTERY, THEN A NON-BSC ATHERECTOMY DEVICE WAS USED ON THE ENTIRE LENGTH OF THE SFA AND POPLITEAL ARTERIES. REPEAT ARTERIOGRAM WAS PERFORMED, AND IT WAS NOTED THAT THE FLOW WAS QUITE SLUGGISH DUE TO DISTAL OBSTRUCTION IN THE ABOVE-KNEE POPLITEAL AND DISTAL SFA. A 5 X 220 BALLOON WAS USED ON THE POPLITEAL AND SFA. FLOW WAS STILL POOR WITH OBSTRUCTIVE DEBRIS WITHIN THE PREVIOUSLY PLACED STENTS. THEREFORE, A 6X120, 130 CM ELUVIA STENT WAS PLACED IN THE POPLITEAL ARTERY, AND A SECOND 6X120, 130 CM ELUVIA STENT WAS PLACED JUST ABOVE THE FIRST STENT, OVERLAPPING BY 1 CM. THE VESSELS WERE THEN DILATED AND FOLLOWING THIS THERE WAS GOOD FLOW BUT WITH A SIGNIFICANT DISSECTION IN THE ABOVE-KNEE POPLITEAL STENT. A 6 X 60 INNOVA STENT WAS THEN PLACED IN THE ABOVE-KNEE POPLITEAL.

  Patient problems: Ischemia; Restenosis

  MAUDE report 21938647 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, AN ARTERIOGRAM WITH RIGHT LEG REVASCULARIZATION WAS PERFORMED DUE TO RIGHT LOWER EXTREMITY REST PAIN IN THE SETTING OF ISCHEMIA. FINDINGS INCLUDED: LEFT EXTERNAL ILIAC ARTERY PATENT WITH SEVERE STENOSIS NOTED; RIGHT COMMON ILIAC STENT PATENT WITH SEVERE GREATER THAN 75% STENOSIS PRESENT; RIGHT EXTERNAL ILIAC ARTERY AND ITS STENTS ALSO DEMONSTRATED SEVERE GREATER THAN 75% STENOSIS RESULTING IN HEMODYNAMICALLY SIGNIFICANT INFLOW OBSTRUCTION; RIGHT COMMON FEMORAL ARTERY AND ITS STENT ARE PATENT WITH IN-STENT RESTENOSIS GREATER THAN 75%; RIGHT SUPERFICIAL FEMORAL ARTERY OCCLUDED THROUGHOUT AND POPLITEAL ARE OCCLUDED DOWN TO THE KNEE. INDEX PROCEDURE ON THE SAME DAY WAS PERFORMED, FROM BOTH ANTEGRADE AND RETROGRADE APPROACH, A 2.0 MM ROTABLATOR DEVICE WAS USED TO PERFORM ATHERECTOMY OF THE COMMON FEMORAL ARTERY, SUPERFICIAL FEMORAL ARTERY (SFA), AND POPLITEAL ARTERIES TO PROVIDE PLAQUE MODIFICATION DIFFUSELY DISEASED AND CALCIFIED ARTERY PRIOR TO ANGIOPLASTY. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED OF THE FEMORAL AND POPLITEAL ARTERIES USING 5 MM PLAIN BALLOON. FOLLOW-UP ANGIOGRAM SHOWED SIGNIF

  Patient problems: Restenosis; Thromboembolism

  MAUDE report 21439979 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH THIS 6X120, 130 CM ELUVIA DRUG-ELUTING STENT AND A RANGER DRUG COATED BALLOON AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION 001 WAS IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT PROXIMAL POPLITEAL ARTERY, AND RIGHT MID-POPLITEAL ARTERY, WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER, WITH LESION LENGTH 150 MM, WITH 100% STENOSIS. THE LESION WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II B LESION. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICES, PRE-DILATION WAS PERFORMED USING 5 MM X 150 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THEN TREATMENT OF THE TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICES 5 MM X 150 MM RANGER DRUG COATED BALLOON AND PLACEMENT OF 6 MM X 120 MM ELUVIA DRUG ELUTING STENT. POST DILATATION WAS PERFORMED WITH 5 MM X 150 MM ARMADA PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN. ON (B)(6) 2024, ARTERIAL STENT EXAM

  Patient problems: Muscle Weakness/Atrophy; Pain; Restenosis

  MAUDE report 21304751 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT IN-STENT THROMBOTIC OCCLUSION AND RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AND ELUVIA DRUG ELUTING STENTS ON (B)(6) 2022 AS A PART OF A CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT COMMON FEMORAL ARTERY, LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), AND LEFT MID SFA WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 177 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH STUDY DEVICES, PRE-DILATION WAS PERFORMED USING A 5 MM X 200 MM NON-BOSTON SCIENTIFIC BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 5 MM X 200 MM AND 6 MM X 200 MM RANGER DRUG COATED BALLOONS AND PLACEMENT OF 6 MM X 120 MM AND 6 MM X 100 MM ELUVIA DRUG ELUTING STENTS STUDY DEVICE. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2024, THE SUBJECT VISITED THE HOSPITAL FOR FOLLOW UP OF PERIPHERAL ARTERY DISEASE, AND VASCULAR ULTRASOUND ANKLE BRACHIAL INDEX (ABI) WITHOUT EXERCISE PERFORMED REVEALED THE FOL

  Patient problems: Arteriosclerosis/ Atherosclerosis; No Clinical Signs, Symptoms or Conditions; Pain; Restenosis; Thrombosis/Thrombus

  MAUDE report 21160480 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN-STENT OCCLUSION OCCURRED. ON (B)(6) 2024, THE PATIENT PRESENTED WITH PERIPHERAL VASCULAR DISEASE WITH ULCERATION OF RIGHT CALF. ARTERIAL DUPLEX SHOWED TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH ISCHEMIA OF THE LOWER LEG. THE PATIENT UNDERWENT A RIGHT LOWER EXTREMITY ARTERIOGRAM FOR FURTHER EVALUATION AND POSSIBLE INTERVENTION FOR LIMB SALVAGE. THE SFA WAS OCCLUDED JUST BEYOND THE ORIGIN AND RECONSTITUTED AT THE LOWER THIGH JUST BELOW HUNTER'S CANAL. THE ABOVE-KNEE POPLITEAL WAS DISEASED TO THE LEVEL OF THE KNEE JOINT. THE BELOW-KNEE POPLITEAL ARTERY APPEARED NORMAL. RUNOFF FILMS SHOWED A PATENT ANTERIOR TIBIAL AND PERONEAL ARTERY THE TOTAL OCCLUSION OF THE POSTERIOR TIBIAL ARTERY. THE ENTIRE LENGTH OF THE SFA AND POPLITEAL ARTERIES TO THE KNEE JOINT WERE TREATED WITH A ROTABLATOR ATHERECTOMY DEVICE WITHOUT DIFFICULTY. A 5 X 200 BALLOON WAS THEN SELECTED AND PASSED DOWN TO THE LEVEL OF THE KNEE JOINT. THE ENTIRE LENGTH OF THE ABOVE-KNEE POPLITEAL AND SFA WERE SERIALLY DILATED. EACH INFLATION TAKEN TO NOMINAL PRESSURE WITH MULTIPLE WAYS NOTED BUT COMPLETE EXPANSION OBTAINED. EACH INFLATION WAS HELD FOR 5 MINUTES, DEFLATED, AND THEN REMOVED. REPEAT

  Patient problems: Obstruction/Occlusion

  MAUDE report 20866495 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RESTENOSIS GUARANTEE PROGRAM. IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THIS 6X120, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN AN ABDOMINAL AORTOGRAM AND LEFT LOWER EXTREMITY ARTERIOGRAM FOR RECANALIZATION OF A LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION. DURING THE PROCEDURE, MECHANICAL ATHERECTOMY OF THE LEFT SFA WAS PERFORMED IN A PROXIMAL TO DISTAL FASHION. POST ANGIOPLASTY WAS PERFORMED USING A 5MM X150MM BALLOON CATHETER. THERE WAS SIGNIFICANT RESIDUAL STENOSIS AND DISSECTION IN THE MID-LEFT SFA; THEREFORE, THE MID AND DISTAL SFA WAS TREATED WITH THIS 6X120, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO IMMEDIATE PROCEDURAL COMPLICATIONS. ON (B)(6) 2024, GREATER THAN 60% RESIDUAL STENOSIS OF THE MID-LEFT SFA WAS NOTED. THIS SEGMENT WAS TREATED WITH A 6MMX140MM NON-BOSTON SCIENTIFIC STENT. POST DILATION WAS PERFORMED USING A 6MM BALLOON. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO PROCEDURAL COMPLICATIONS.

  Patient problems: Restenosis

  MAUDE report 20582051 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2024, THE PATIENT PRESENTED WITH ATHEROSCLEROSIS OF NATIVE ARTERIES OF EXTREMITIES WITH INTERMITTENT CLAUDICATION AND REST PAIN IN THE LEFT LEG. THE PATIENT HAD SEVERE LOWER LEG PAIN AND LOSS OF SENSATION IN THE LEFT FOOT FOR THE PAST 2 WEEKS AND WAS UNABLE TO SLEEP DUE TO LEFT FOOT PAIN. THE PATIENT UNDERWENT LEFT TO LOWER EXTREMITY ARTERIOGRAM, WHICH REVEALED LONG SEGMENT OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY WITH THE TWO-VESSEL RUNOFF TO FOOT. THERE WAS SUCCESSFUL RECANALIZATION OF THE LEFT FEMOROPOPLITEAL SEGMENT USING 3.4MM JETSTREAM ATHERECTOMY FOR A TOTAL OF 18.52 MINUTES, FOLLOWED BY 5MM X 150MM BALLOON ANGIOPLASTY, AND THEN PLACEMENT OF A 6MM X 120MM ELUVIA DRUG-ELUTING STENT IN THE DISTAL SFA/PROXIMAL POPLITEAL ARTERY. POST DILATION PERFORMED USING A 5MM X 150MM BALLOON. NO RESIDUAL STENOSIS. PATIENT TOLERATED THE PROCEDURE WELL. NO IMMEDIATE PROCEDURAL COMPLICATIONS. ON (B)(6) 2024, THE PATIENT PRESENTED WITH ATHEROSCLEROSIS OF NATIVE ARTERIES OF EXTREMITIES WITH REST PAIN IN THE LEFT LEG. THERE WAS WORSENING OF LEFT FOOT PAIN FOR THE PAST 2 WEEKS WITH DUPLEX EVIDE

  Patient problems: Restenosis

  MAUDE report 19922022 ↗
• MalfunctionJul 25, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. A 6X120, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR A PROCEDURE. DURING THE DEPLOYMENT, HOWEVER, THE STENT BECAME STUCK. NO FURTHER INFORMATION HAS BEEN RECEIVED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827063 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY: IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH TWO 6X120, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENTS AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA, EXTENDING UP TO THE LEFT DISTAL SFA WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER, AND 5 MM DISTAL REFERENCE VESSEL DIAMETER, WITH LESION LENGTH 230 MM, WITH 100% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICES, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM STERLING OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. TREATMENT OF THE TARGET LESION WAS THEN PERFORMED BY PLACEMENT OF THESE TWO 6 MM X 120 MM ELUVIA DRUG ELUTING STENTS STUDY DEVICES. POST-DILATION WAS PERFORMED USING 5 MM X 120 MM STERLING OVER-THE-WIRE PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR REINTERVENT

  Patient problems: Ischemia; Restenosis; Unspecified Tissue Injury

  MAUDE report 19632987 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH TWO 6X120, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENTS AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA, EXTENDING UP TO THE LEFT DISTAL SFA WITH 5.5 MM PROXIMAL REFERENCE VESSEL DIAMETER, AND 5 MM DISTAL REFERENCE VESSEL DIAMETER, WITH LESION LENGTH 230 MM, WITH 100% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICES, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM STERLING OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. TREATMENT OF THE TARGET LESION WAS THEN PERFORMED BY PLACEMENT OF THESE TWO 6 MM X 120 MM ELUVIA DRUG ELUTING STENTS STUDY DEVICES. POST-DILATION WAS PERFORMED USING 5 MM X 120 MM STERLING OVER-THE-WIRE PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2023, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR REINTERVENT

  Patient problems: Ischemia; Restenosis; Unspecified Tissue Injury

  MAUDE report 19632957 ↗