ELUVIA™ H74939294600810Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729876595), received between Jun 8, 2022 and Mar 26, 2026 — classified as 1 death, 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Nonstandard Device; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO POSITION. A 6X80, 130 CM ELUVIA SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE PHYSICIAN PERFORMED A COMMON FEMORAL ENDARTERECTOMY ALONG WITH AN IPSILATERAL EXTERNAL ILIAC STENT PLACEMENT. HOWEVER, UPON DEPLOYMENT, IT WAS NOTED THAT THE STENT EXTENDED INTO THE AREA OF THE ENDARTERECTOMY. IT FELT LIKE IT WAS DEPLOYED LONGER THAN 80CM. THE SAME AREA WAS THEN STENTED WITH A SHORTER ELUVIA AFTER REMOVING THE STENT FROM THE OPEN ENDARTERECTOMY, AND THE PROCEDURE WAS COMPLETED. THE STENT SHAFT HAD NOT BEEN ADVANCED VERY FAR INTO THE PATIENT, AND THE PHYSICIAN MAY HAVE BEEN HOLDING THE SILVER SLIDING PORTION OF THE DELIVERY CATHETER, WHICH COULD POTENTIALLY LEAD TO A DEPLOYMENT ERROR. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700137 ↗
• MalfunctionMar 24, 2026Nonstandard Device; Difficult or Delayed Activation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIALLY DEPLOYED OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERE CALCIFIED LEFT EXTERNAL ILIAC ARTERY. A 6X80, 130 CM ELUVIA STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN TRYING TO DEPLOY THE DEVICE, IT WAS OBSERVED THAT THE THUMB WHEEL WOULD NOT DEPLOY THE DEVICE AND THE PULL GRIP WOULD NOT DEPLOY THE DEVICE EITHER. THE DEVICE WAS THEN DEPLOY MANUALLY USING THE PIN AND PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680631 ↗
• 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 23839094 ↗
• MalfunctionJul 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A POSSIBLE STERILITY ISSUE. AN ELUVIA? WAS SELECTED FOR USE. UPON DEVICE PREPARATION, IT WAS OBSERVED THAT THERE WAS A PUNCTURE OR HOLE IN THE PLASTIC DEVICE PACKAGING. IT WAS SUSPECTED THAT THE STERILITY OF THE INNER POUCH OF THE PACKAGING WAS COMPROMISED. THE DEVICE WAS NOT OPENED, AND WAS EXCHANGED FOR ANOTHER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22651284 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING TREATMENT WITH ADDITIONAL DEVICES. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AND ELUVIA DRUG ELUTING STENTS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, LEFT DISTAL SUPERFICIAL FEMORAL ARTERY, LEFT PROXIMAL POPLITEAL ARTERY EXTENDING UP TO LEFT MID POPLITEAL ARTERY WITH 7 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 410 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM COYOTE PTA BALLOON AND 6 MM X 220 MM STERLING PTA BALLOON FOLLOWED BY ATHERECTOMY USING 2.3 MM CATHETER BALLOON TURBO POWER ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 6 MM X 200 MM AND 6 MM X 100 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES FOLLOWED BY THE PLACEMENT OF TWO 6 MM X 80 MM ELUVIA DRUG ELUTING STENTS STUDY DEVICES. FOLLOWING POST TREATMENT, DILATION WAS PERFORMED BY USING 7 MM X 150 MM

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion; Ulcer; Vascular Dissection

  MAUDE report 19110966 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL: IT WAS REPORTED THAT RESTENOSIS OCCURRED, REQUIRING TREATMENT WITH ADDITIONAL DEVICES. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AND ELUVIA DRUG ELUTING STENTS ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, LEFT MID SUPERFICIAL FEMORAL ARTERY, LEFT DISTAL SUPERFICIAL FEMORAL ARTERY, LEFT PROXIMAL POPLITEAL ARTERY EXTENDING UP TO LEFT MID POPLITEAL ARTERY WITH 7 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 410 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM COYOTE PTA BALLOON AND 6 MM X 220 MM STERLING PTA BALLOON FOLLOWED BY ATHERECTOMY USING 2.3 MM CATHETER BALLOON TURBO POWER ATHERECTOMY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING 6 MM X 200 MM AND 6 MM X 100 MM RANGER DRUG-COATED BALLOONS STUDY DEVICES FOLLOWED BY THE PLACEMENT OF TWO 6 MM X 80 MM ELUVIA DRUG ELUTING STENTS STUDY DEVICES. FOLLOWING POST TREATMENT, DILATION WAS PERFORMED BY USING 7 MM X 150 M

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion; Ulcer; Vascular Dissection

  MAUDE report 19105732 ↗
• InjuryJan 25, 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) 2023, THE PATIENT HAD MORE THAN 80% STENOSIS IN THE PROXIMAL POPLITEAL ARTERY. SUCCESSFUL RECANALIZATION OF THE RIGHT FEMOROPOPLITEAL SEGMENT USING JETSTREAM ATHERECTOMY, 5 MM BALLOON ANGIOPLASTY, AND 6 MM X 80 MM DRUG-ELUTING STENT PLACEMENT. THE 6MM X 80MM X 130CM ELUVIA DRUG-ELUTING VASCULAR STENT WAS PLACED IN THE PROXIMAL POPLITEAL ARTERY. POST-INTERVENTION ANGIOGRAPHY SHOWED RIGHT FEMOROPOPLITEAL SEGMENT WIDELY PATENT WITH TWO-VESSEL ANTERIOR TIBIAL AND PERONEAL RUNOFF TO RIGHT FOOT. ON (B)(6) 2024, RECANALIZATION OF RIGHT FEMOROPOPLITEAL SEGMENT WITH ATHERECTOMY, BALLOON ANGIOPLASTY, AND THE DRUG-ELUTING STENT PLACEMENT WAS PERFORMED. THERE WAS MORE THAN 70% STENOSIS IN MID SUPERFICIAL FEMORAL ARTERY (SFA). FOCAL, PRE-OCCLUSIVE STENOSIS IN DISTAL RIGHT SFA AT THE PROXIMAL END OF THE RIGHT SFA STENT. DIFFUSE, MORE THAN 80% STENOSIS OF THE MID AND DISTAL RIGHT POPLITEAL ARTERY WITH THE PERONEAL RUNOFF TO FOOT. MECHANICAL ATHERECTOMY OF THE STENO-OCCLUSIVE DISEASE IN RIGHT FEMOROPOPLITEAL SEGMENT PERFORMED IN A PROXIMAL TO DISTAL FASHION FOR A TOTAL OF 5.31 MINUTES, THEN, POST ANGIOPLASTY PERFORMED USING 5MM X 80MM BA

  Patient problems: Restenosis

  MAUDE report 18584491 ↗
• InjuryJan 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS IN-STENT THROMBOSIS AND A POTENTIAL STENT FRACTURE. A 6MM X 80MM, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN AN ANGIOPLASTY AND STENTING PROCEDURE TO TREAT THROMBOSIS. ON (B)(6) 2023, ANGIOPLASTY WAS PERFORMED FOLLOWED BY SUCCESSFUL DEPLOYMENT OF THE ELUVIA STENT WITH A SUBINTIMAL APPROACH DUE TO SEVERE PERIPHERAL ARTERIAL DISEASE. ON (B)(6) 2024, THE PATIENT HAD A VASCULAR LAB FOLLOW-UP WHERE LOW PARAMETERS WERE NOTED, AND THE PATIENT WAS REFERRED TO ANGIOGRAPHY. ON JANUARY 10, 2024, ANGIOGRAPHY SHOWED THROMBOSIS INSIDE THE ELUVIA STENT, AND THE PHYSICIAN SUSPECTED A POSSIBLE STENT FRACTURE. THROMBO-ASPIRATION WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC DEVICE, AND THE THROMBUS WAS SUCCESSFULLY REMOVED. ADDITIONALLY, A NON-BOSTON SCIENTIFIC STENT AND AN INNOVA STENT WERE DEPLOYED INSIDE THE ELUVIA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18544370 ↗
• InjuryDec 13, 2023Adverse 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 REVASCULARIZATION. ON (B)(6) 2022, THE SUBJECT UNDERWENT TREATMENT WITH THIS 6X80, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM AND A RANGER DRUG COATED BALLOON AS PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT MID-SFA, EXTENDING UP TO RIGHT DISTAL SFA WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER, AND 5 MM DISTAL REFERENCE VESSEL DIAMETER, WITH LESION LENGTH 200 MM WITH 100% STENOSIS, AND WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED, AND PRE-DILATION WAS PERFORMED BY USING A 3 MM X 25 MM NON-BOSTON SCIENTIFIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, A 4 MM X 220 MM PTA BALLOON, A 5 MM X 200 MM PTA BALLOON, AND A 5 MM X 120 MM PTA BALLOON. TREATMENT OF THE TARGET LESION WAS THEN PERFORMED BY DILATION USING THE STUDY DEVICES, A 6 MM X 200 MM RANGER DRUG COATED BALLOON, AND THIS 6 MM X 80 MM ELUVIA DRUG ELUTING STENT. POST-DILATION WAS PERFORMED USING A 5 MM X 60 MM PTA BALLOON, AND THE FINAL RESIDUAL STENOS

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion

  MAUDE report 18318434 ↗
• InjuryMay 18, 2023Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE CATHETER OF THE DELIVERY SYSTEM BECAME STUCK ON THE STENT, AND BOTH THE STENT AND CATHETER TIP BROKE OFF WITHIN THE PATIENT. AN ENDARTERECTOMY WAS PERFORMED TO REMOVE THE STENT AND CATHETER FRAGMENTS. A 6X80, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN THE PROCEDURE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS REPORTED TO HAVE BOTH MODERATE TORTUOSITY AND CALCIFICATION. WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LESION, THERE WAS RESISTANCE NOTED. WHEN THE STENT WAS FULLY DEPLOYED, IT WOULD NOT RELEASE FROM THE CATHETER. THE CATHETER OF THE DELIVERY SYSTEM BECAME STUCK ON THE STENT, AND BOTH THE STENT AND CATHETER TIP BROKE OFF WITHIN THE PATIENT. AN ENDARTERECTOMY WAS PERFORMED TO REMOVE THE STENT AND FRAGMENT OF THE CATHETER. THE STENT WAS FULLY INTACT UNTIL IT WAS RETRIEVED. IT WAS UNKNOWN WHETHER ANY DEVICE FRAGMENTS REMAINED WITHIN THE PATIENT. THERE WERE NO FURTHER ADVERSE CONSEQUENCES REPORTED FOR THE PATIENT POST PROCEDURE. THE PATIENT'S STATUS WAS OK.

  Patient problems: Foreign Body In Patient

  MAUDE report 16953630 ↗
• 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 16018334 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY, PROXIMAL POPLITEAL ARTERY AND MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 7 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.5 MM WITH LESION LENGTH OF 410 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED FOLLOWED BY PRE DILATION WITH 4 MM X 220 MM COYOTE AND 6 MM X 220 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH 6 MM X 200 MM AND 6 MM X 100 MM RANGER DRUG COATED BALLOON AND IMPLANTING TWO ELUVIA DRUG ELUTING STENT OF 6 MM X 80 MM. FOLLOWING POST DILATATION WITH 7 MM X 150 MM NON-BOSTON SCIENTIFIC PTA BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022, SUBJECT VISITED THE HOSPITAL WITH COMPLAINTS OF LIMITED ACTIVITIES

  Patient problems: Restenosis; Vascular Dissection

  MAUDE report 15400714 ↗
• InjurySep 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY, PROXIMAL POPLITEAL ARTERY AND MID POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 7 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5.5 MM WITH LESION LENGTH OF 410 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, ATHERECTOMY WAS PERFORMED FOLLOWED BY PRE DILATION WITH 4 MM X 220 MM COYOTE AND 6 MM X 220 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH 6 MM X 200 MM AND 6 MM X 100 MM RANGER DRUG COATED BALLOON AND IMPLANTING TWO ELUVIA DRUG ELUTING STENT OF 6 MM X 80 MM. FOLLOWING POST DILATATION WITH 7 MM X 150 MM NON-BOSTON SCIENTIFIC PTA BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022, SUBJECT VISITED THE HOSPITAL WITH COMPLAINTS OF LIMITED ACTIVITIES

  Patient problems: Restenosis; Vascular Dissection

  MAUDE report 15397935 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY: IT WAS REPORTED THAT AN OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), MID SFA AND DISTAL SFA WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6 MM WITH LESION LENGTH OF 310 MM AND 100% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO TARGET LESION TREATMENT, PRE DILATION WAS PERFORMED WITH 5 MM X 250 MM NON-BOSTON SCIENTIFIC PERCUTANEOUS ANGIOPLASTY (PTA) BALLOON, 5 MM X 120 MM AND 4 MM X 60 MM NON-BOSTON SCIENTIFIC PTA BALLOON, 4 MM X 150 MM NON-BOSTON SCIENTIFIC PTA BALLOON, 2 MM X 30 MM AND 4 MM X 30 MM NON-BOSTON SCIENTIFIC DRUG COATED BALLOON AND 5 MM X 120 MM NON-BOSTON SCIENTIFIC PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF STUDY DEVICES, TWO 6 MM X 120 MM AND ONE 6 MM X 80 MM ELUVIA DRUG-ELUTING STENT. FOLLOWING POST DILATION WITH 6 MM X 200 MM NON-BOSTON SCIENTIFIC PTA BALLOON AND 6 MM X 60 MM STERLING BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED WITH CLOPIDOGRE

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion

  MAUDE report 14632304 ↗