ELUVIA™ H74939294601010Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729876601), received between May 3, 2019 and Jul 14, 2026 — classified as 1 death, 13 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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 20 most recent of 20 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 25818490 ↗
• InjuryApr 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING AN ADDITIONAL DEVICE. ON (B)(6) 2023 THE SUBJECT UNDERWENT TREATMENT WITH THE 6X100, 130 CM ELUVIA DRUG-ELUTING STENT 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 TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) A LESION. TREATMENT OF THE 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 PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA, LEFT DISTAL SFA, EXTENDING UP TO THE 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 THE STUDY DEVICE, LITHOTRIPSY WAS PERFORMED USING 6 MM X 60 MM SHOCKWAVE M5+ LITHOTR

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

  MAUDE report 21830246 ↗
• MalfunctionMar 18, 2025Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 6X100, 130 CM ELUVIA WAS SELECTED FOR USE. DURING ADVANCEMENT OVER A 035 NON-BOSTON SCIENTIFIC GUIDEWIRE, HALF OF THE STENT ACCIDENTLY DEPLOYED PRIOR TO ENTERING THE PATIENT. THE DEVICE WAS REMOVED AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633970 ↗
• 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 21437856 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT OCCLUSION OCCURRED. ON (B)(6) 2024, THE PATIENT UNDERWENT INTRAVASCULAR ULTRASOUND EVALUATION OF LEFT ILIAC, COMMON FEMORAL, SUPERFICIAL FEMORAL, POPLITEAL, AND ANTERIOR TIBIAL ARTERIES FOR DIAGNOSTIC AND INTERVENTION PLANNING PURPOSES. LEFT SUPERFICIAL FEMORAL ARTERY WAS HEAVILY DISEASED WITH SCATTERED AREAS OF STENOSIS THROUGHOUT THE PROXIMAL THIGH AND CHRONIC TOTAL OCCLUSION IN THE MID-THIGH. POPLITEAL RECONSTITUTES AT THE PATELLA. SINGLE-VESSEL RUNOFF THROUGH THE ANTERIOR TIBIAL ARTERY WHICH IS DISEASED WITH MOST NOTABLE STENOSIS GREATER THAN 75% IN THE PROXIMAL CALF BUT PATENT DOWN TO THE FOOT. ATHERECTOMY WAS PERFORMED IN THE CHRONICALLY OCCLUDED LEFT SUPERFICIAL FEMORAL AND POPLITEAL USING A 1.5MM ROTABLATOR DEVICE. BALLOON ANGIOPLASTY WAS PERFORMED USING A 6MM BALLOON. THERE WAS A NOTABLE FLOW-LIMITING DISSECTION WITHIN THE SUPERFICIAL FEMORAL WHICH WAS STENTED USING 7X120MM, 7X120MM, AND 6X100MM ELUVIA DRUG-COATED SELF-EXPANDING STENTS. GOOD RESULT FROM REVASCULARIZATION WITH RESTORED VESSEL IN LINE FLOW TO THE FOOT THROUGH THE ANTERIOR TIBIAL ARTERY. THERE WAS RESIDUAL DISSECTION PROXIMAL AND DISTAL TO THE SUPERFICIAL FEMORAL STENTS BUT DID N

  Patient problems: Obstruction/Occlusion

  MAUDE report 20224624 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY: IT WAS REPORTED THAT STENT OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 80 MM AND 90% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, A 7 MM NON-BOSTON SCIENTIFIC (BSC) EMBOLIZATION PROTECTION DEVICE WAS USED, AND ATHERECTOMY WAS PERFORMED WITH A 4 MM X 80 MM NON-BSC ATHERECTOMY DEVICE. PRE-DILATION WAS PERFORMED WITH A 4.0 MM X 80 MM NON-BSC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, 6.0 MM X 80 MM STERLING PTA BALLOON, AND 6.0 MM X 80 MM NON-BSC PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED WITH PLACEMENT OF THE 6.0 MM X 100 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING POST TREATMENT, DILATION WAS PERFORMED WITH A 6 MM X 80 MM STERLING PTA BALLOON, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 202

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

  MAUDE report 20101544 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT AN OCCLUSION OF THE STENT OCCURRED REQUIRING INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENT ON 27-JUN-2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, RIGHT MID SUPERFICIAL FEMORAL ARTERY, RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY, RIGHT PROXIMAL POPLITEAL ARTERY EXTENDING UP TO RIGHT MID POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 440 MM WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED USING 1.5 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED USING 5 MM X 200 MM NON-BSC PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5 MM X 200 MM RANGER DRUG-COATED BALLOON FOLLOWED BY PLACEMENT OF 6 MM X 100 MM ELUVIA DRUG ELUTING STENT. FOLLOWING POST-DILATION USING 5 MM X 200 MM NON-BSC PTA BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON 27-JUN-2023, THE SUBJECT WAS

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 18243170 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELUVIA RESTENOSIS PROGRAM: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVASCULARIZATION PROCEDURE 272 DAYS FOLLOWING THE INDEX PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT AN ATHERECTOMY PROCEDURE TO TREAT ATHEROSCLEROTIC PERIPHERAL VASCULAR DISEASE WITH CLAUDICATION. THE TARGET LESION WAS LOCATED WITHIN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND P1 POPLITEAL ARTERY. RETROGRADE ACCESS WAS OBTAINED TO THE RIGHT COMMON FEMORAL ARTERY. USING IMAGING GUIDANCE, A CATHETER AND GUIDEWIRE WERE POSITIONED ACROSS THE AREA OF STENOSIS. A NON-BSC FILTER WIRE WAS POSITIONED IN THE P3 POPLITEAL ARTERY. MECHANICAL ATHERECTOMY IN THE LEFT SFA AND POPLITEAL ARTERY WAS THEN PERFORMED USING A JETSTREAM CATHETER. PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY WAS THEN PERFORMED USING AN UNKNOWN BALLOON ALONG THE LENGTH OF THE SFA AND P1 POPLITEAL ARTERY. FOLLOW-UP IMAGING DEMONSTRATED SUBOPTIMAL RESULTS. BALLOON ANGIOPLASTY WAS REPEATED, BUT NO SIGNIFICANT CHANGE WAS NOTED. TRANSCATHETER STENTING WAS THEN PERFORMED AT THE P1 POPLITEAL ARTERY WITH AN ELUVIA DRUG-ELUTING VASCULAR STENT. THE STENT WAS POST DILATED USING AN UNKNOWN 6X100 MM BALLOON. FOLLOW-UP IMAGING DEMONSTRATED EXCELLENT RESULTS

  Patient problems: Restenosis

  MAUDE report 17087742 ↗
• MalfunctionMay 9, 2023Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE. A 6X100, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN THE EXTREMELY TORTUOUS, HIGHLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE ELUVIA STENT WAS DEPLOYED IN THE SFA, BUT THE DELIVERY SYSTEM WAS UNABLE TO BE PULLED BACK THROUGH THE NON-BOSTON SCIENTIFIC 6F SHEATH. THEREFORE, BOTH DEVICES WERE REMOVED TOGETHER. BOTH DEVICES HAD ACCORDIONED DUE TO THE HEAVY CALCIUM. A SECOND STENT WAS PLACED WITHOUT INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED. AFTER IMPLANTING THE STENT, THE DELIVERY SYSTEM AND WIRE WERE REMOVED TOGETHER. THE DEVICE WAS REMOVED INTACT. THE SECOND STENT WAS ORIGINALLY PLANNED AS PART OF THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900167 ↗
• DeathDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN ETIOLOGY. ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT WITH THREE ELUVIA DRUG ELUTING STENTS AS A PART OF A CLINICAL STUDY. THE TARGET LESION WAS LOCATED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), MID SFA, DISTAL SFA AND RIGHT PROXIMAL POPLITEAL ARTERY. THE TARGET LESION HAD A PROXIMAL REFERENCE VESSEL DIAMETER OF 5.1 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4.6 MM. THE TARGET LESION WAS 90 PERCENT STENOSED AND 300 MM IN LENGTH, AND WAS CLASSIFIED AS TASC II C LESION. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT OF THREE ELUVIA DRUG ELUTING STENTS OF 6.0 MM X 120 MM, 6 MM X 100 MM, AND 6 MM X 80 MM. FOLLOWING STENT PLACEMENT, POST DILATION OF THE TARGET LESION WAS PERFORMED WITH 5 MM X 200 MM AND 5 MM X 80 MM MUSTANG PTA BALLOON. THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE ZERO PERCENT, AND THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED WITH ASPIRIN. ON (B)(6) 2022, WHILE ATTEMPTING TO SCHEDULE A 6-MONTH FOLLOW-UP APPOINTMENT, THE STUDY SITE WAS INFORMED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT HAD EXPIRED AT SOME POINT FOLLOWING (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018715 ↗
• InjuryApr 14, 2022Fracture; Fracture

  (B)(4) CLINICAL TRIAL: IT WAS REPORTED THIS STENT HAD RESTENOSIS AND INTERNAL DEVICE FRACTURE. THE SUBJECT UNDERWENT TREATMENT WITH THE 6.0MM X 100MM ELUVIA DRUG ELUTING STENT ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5MM. THE LESION WAS 100MM LONG , 100% STENOSED, AND CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT, PRE DILATION WAS PERFORMED USING A 5MM X 150MM MUSTANG PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY IMPLANTING A 6.0MM X 100MM ELUVIA, AND THE RESIDUAL STENOSIS WAS NOTED TO BE 0%. THE PATIENT WAS DISCHARGED THE SAME DAY ON CLOPIDOGREL. DURING TREATMENT OF THE TARGET LESION, DISSECTION OF GRADE B WAS NOTED POST ANGIOPLASTY WITH 5 MM X 150 MM MUSTANG BALLOON. IN RESPONSE TO THE EVENT 6.0 MM X 100 MM ELUVIA STENT WAS IMPLANTED. FOLLOWING POST DILATATION WITH 5.0 MM X 150 MM MUSTANG PTA BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. THE COMPLICATION WAS RESOLVED. ON (B)(6) 2022, THE SUBJECT PRESENTED WITH THE

  Patient problems: Arteriosclerosis/ Atherosclerosis; Pain; Restenosis

  MAUDE report 14115904 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY . IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG ELUTING STENT ON OCTOBER 12, 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING TO RIGHT PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.5 MM WITH LESION LENGTH OF 100 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. TREATMENT OF FIRST TARGET LESION WAS PERFORMED BY PLACEMENT OF STUDY DEVICE, ELUVIA DRUG ELUTING STENT OF 6.0 MM X 120 MM. POST TREATMENT FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. THE SECOND TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY EXTENDING TO RIGHT MID SUPERFICIAL FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.5 MM WITH LESION LENGTH OF 80 MM AND 90% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. TREATMENT OF SECOND TARGET LESION WAS PERFORMED BY PLACEMENT OF STUDY DEVICE; ELUVIA DRUG ELUTING STENT OF 6.0 MM X 100 MM. POST TREATMENT FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON OCTOBER 12, 2021, ON TH

  Patient problems: Vascular Dissection

  MAUDE report 14048309 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT A DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG ELUTING STENT ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE ENTIRE LENGTH OF RIGHT SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT, PREDILATION WAS PERFORMED WITH A 5 MM X 200 MM MUSTANG PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF ONE 6.0 MM X 120 MM AND, TWO 6 MM X 100 MM ELUVIA DRUG COATED STUDY STENTS. POST DILATION WAS PERFORMED WITH A 5 MM X 200 MM MUSTANG PTA BALLOON. FOLLOWING POST DILATION, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON (B)(6) 2021, DURING TREATMENT OF THE TARGET LESION, DISSECTION OF SEVERITY GRADE C WAS NOTED WITH RESIDUAL STENOSIS OF 30%. AS A RESPONSE TO THE EVENT, BAILOUT STENT WAS IMPLANTED FOLLOWED BY BALLOON DILATION WAS PERFORMED, AND THE COMPLICATION WAS RESOLVED. IT WAS FURTHER REPORTED THAT DURING TREATMENT OF THE TARG

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 12724686 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT A DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG ELUTING STENT ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE ENTIRE LENGTH OF RIGHT SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 300 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT, PREDILATION WAS PERFORMED WITH A 5 MM X 200 MM MUSTANG PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF ONE 6.0 MM X 120 MM AND, TWO 6 MM X 100 MM ELUVIA DRUG COATED STUDY STENTS. POST DILATION WAS PERFORMED WITH A 5 MM X 200 MM MUSTANG PTA BALLOON. FOLLOWING POST DILATION, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON (B)(6) 2021, DURING TREATMENT OF THE TARGET LESION, DISSECTION OF SEVERITY GRADE C WAS NOTED WITH RESIDUAL STENOSIS OF 30%. AS A RESPONSE TO THE EVENT, BAILOUT STENT WAS IMPLANTED FOLLOWED BY BALLOON DILATION WAS PERFORMED, AND THE COMPLICATION WAS RESOLVED. IT WAS FURTHER REPORTED THAT DURING TREATMENT OF THE TARG

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 12724635 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT DISSECTION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON, AND TWO ELUVIA DRUG ELUTING STENTS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE ENTIRE LENGTH OF LEFT SFA (PROXIMAL, MID, DISTAL SFA) EXTENDING INTO LEFT PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4.5 MM WITH LESION LENGTH OF 360 M AND 100% STENOSIS. PRE-DILATATION WAS PERFORMED, AND TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION WITH STUDY DEVICES, RANGER DRUG COATED BALLOON 5 MM X 150 MM AND ELUVIA DRUG ELUTING STENTS OF SIZES 6 MM X 120 MM AND 6 MM X 100 MM WERE IMPLANTED. POST TARGET LESION TREATMENT WAS DONE BY STENTING WITH NON-BSC DRUG ELUTING STENT DUE TO DISSECTION OF GRADE E AND RESIDUAL STENOSIS NOTED. FOLLOWING POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE COMPLICATION WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 12558896 ↗
• MalfunctionApr 13, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABELING WAS INCORRECT. THE 100MM TARGET LESION WAS LOCATED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). A 6MM X 100MM X 130CM ELUVIA SELF EXPANDING STENT WAS SELECTED TO BE IMPLANTED. THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE PATIENT. PRIOR TO DEPLOYMENT IT WAS OBSERVED BY THE PHYSICIAN THAT THE STENT APPEARED VERY SHORT ON FLUOROSCOPY. THE BOX AND INTERNAL PACKAGING CONFIRMED THE SIZE TO BE 6MM X 100MM X 130CM. THE PHYSICIAN CHECKED THE STENT DELIVERY HANDLE AND IT WAS LABELED 6MM X 40MM X 130CM. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. A NEW 6MM X 100MM X 130CM STENT WAS SELECTED AND DEPLOYED WITHOUT ANY ISSUE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655471 ↗
• MalfunctionMar 24, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE STENT INSIDE THE PACKAGING WAS THE INCORRECT SIZE. AN ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A PROCEDURE WITHIN THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION WAS APPROXIMATELY 100MM LONG. DURING PREPARATION, UPON REMOVAL FROM PACKAGING, THE DEVICE WAS FOUND TO BE THE INCORRECT SIZE. THE PACKAGE WAS LABELED 6MM X 100MM, BUT THE STENT INSIDE WAS 6MM X 40MM. THE STENT APPEARED SHORTER THAN THE EXPECTED 100MM LENGTH, AND THE HANDLE OF THE DEVICE HAD 6 X 40 PRINTED ON IT. IT WAS NOTED THAT THE INNER POUCH MATCHED THE OUTER CARTON/SHELF CARTON. THE STENT WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6MM X 100MM ELUVIA WITHOUT ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565996 ↗
• InjuryDec 18, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE STENT WAS DEPLOYED AND FOUND TO BE SHORTER THAN ITS LABELED SIZE, REQUIRING ADDITIONAL INTERVENTION. A 6MM X 100MM X 130CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION. DURING THE PROCEDURE, THE STENT WAS DEPLOYED, BUT IT WAS NOTED TO BE SHORTER THAN 100MM. THE DEVICE DID NOT APPEAR TO BE COMPRESSED OR FORESHORTENED. USING AN 80MM BALLOON FOR REFERENCE, THE DEPLOYED STENT WAS THOUGHT TO BE 40MM IN LENGTH. ANOTHER 6MM X 100 MM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE AND DEPLOYED ACROSS THE PREVIOUSLY PLACED SHORTER STENT. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER CLARIFIED THAT THE FIRST ELUVIA WAS NOT DEPLOYED WHEN IT WAS OBSERVED TO BE SHORTER THAN THE 100MM LENGTH IT WAS SUPPOSED TO BE FROM THE PACKAGING. THE STENT WAS REMOVED AND DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11037835 ↗
• MalfunctionJul 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER BROKE. A 6X100X130 ELUVIA SELF-EXPANDING STENT WAS SELECTED FOR USE. THE STENT WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT INCIDENT. UPON REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE PATIENT, THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED, AND THE PATIENT CONDITION POST-PROCEDURE WAS REPORTED AS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10326112 ↗
• MalfunctionMay 3, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. A 6X100X130 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) CHRONIC TOTAL OCCLUSION (CTO). DURING THE PROCEDURE, THE FIRST 2 STENTS WERE DELIVERED SUCCESSFULLY. WHEN ATTEMPTING TO DELIVER THE LAST STENT, IT DEPLOYED DIRECTLY INFO THE NON-BSC SHEATH. THE LOCKING MECHANISM WAS STILL ON THE THUMBWHEEL. THERE WAS NO RESISTANCE WHEN ADVANCING THE DEVICE THROUGH THE SHEATH. THE SHEATH WAS REMOVED WITH THE DEPLOYED STENT IN IT, AND REPLACED WITH ANOTHER ONE. A NEW ELUVIA STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577821 ↗