ELUVIA™ H74939294600410Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729876571), received between Mar 20, 2019 and Sep 18, 2025 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED, AND ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS PREPARED AND SEDATED IN A SUPINE POSITION ON A FLUOROSCOPIC TABLE, BOTH GROINS WERE PREPPED AND DRAPED IN THE USUAL FASHION. LOCAL INFILTRATIVE ANESTHESIA WAS ADMINISTERED USING A 1% XYLOCAINE WITHOUT EPINEPHRINE. THE SITE RIGHT ULTRASOUND WAS USED FOR REAL-TIME IMAGING FOR NEEDLE ENTRY INTO THE RIGHT COMMON FEMORAL ARTERY WITH PHOTOGRAPHIC DOCUMENTATION. A VERSED AND FENTANYL WAS GIVEN TO THE PATIENT IN SMALL INCREMENTS THROUGH THE COURSE OF THE PROCEDURE FOR COMFORT. A 20-GAUGE MICROPUNCTURE NEEDLE WAS USED AND 0.018 WIRE PASSED FOLLOWED BY THE 4 FRENCH INTRODUCER. A 0.035 GLIDEWIRE WAS PASSED TO THE SUPRARENAL AORTA AND A 5 FRENCH SHEATH WAS PLACED. AN OMNI FLUSH CATHETER WAS PASSED TO THE LEVEL OF L1 AND AN ABDOMINAL AORTOGRAM WAS PERFORMED WITH HALF-STRENGTH CONTRAST AND HAND-INJECTION TO MINIMIZE CONTRAST LOAD AS THE PATIENT HAS CHRONIC RENAL INSUFFICIENCY CREATININE OF 1.8, THIS SHOWED MESENTERIC AND RENAL VESSELS TO BE WIDELY PATENT. THERE WAS A PREVIOUS STENT IN THE SUPERIOR ME

  Patient problems: Pain; Restenosis

  MAUDE report 23085991 ↗
• InjuryMar 20, 2025Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. A 6X40, 130 CM ELUVIA SELF-EXPANDING STENT WAS SELECTED FOR A FISTULAGRAM. PHYSICIAN USED THROMBECTOMY AND ANGIOPLASTY IN THE SUBCLAVIAN ARTERY. THE SUBCLAVIAN ARTERY HAD A TIGHT LESION, EVEN AFTER ANGIOPLASTY, AND THE PHYSICIAN THEN REQUESTED THE 6X40, 130 CM ELUVIA SELF-EXPANDING STENT. WHEN DEPLOYING THE ELUVIA, GOOD PLACEMENT WAS NOT ACHIEVED, AND THE STENT WAS UNDERSIZED. THE STENT THEN STARTED TO MIGRATE. ATTEMPTS TO RETRIEVE THE STENT WERE UNSUCCESSFUL, SO THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR INTERVENTION. IT WAS FURTHER REPORTED THAT THE STENT WAS SUCCESSFULLY REMOVED. THE PATIENT IS DOING FINE. IT WAS AGAIN FURTHER REPORTED THAT THE 100% STENOSED LESION WAS LOCATED IN A VERY TORTUOUS SUBCLAVIAN ARTERY. AT THE OTHER HOSPITAL, THE STENT WAS SURGICALLY REMOVED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657965 ↗
• MalfunctionDec 18, 2024Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT OCCURRED OUTSIDE THE PATIENT. A 6X40, 130 CM ELUVIA WAS SELECTED FOR USE. DURING INTRODUCTION ONTO THE GUIDEWIRE, THE STENT DEPLOYED OUTSIDE THE PATIENTS BODY. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20967915 ↗
• MalfunctionNov 20, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. THIS 6X40, 130 CM ELUVIA STENT WAS SELECTED FOR USE IN AN ARTERIAL STENTING PROCEDURE. UPON OPENING THE PACKAGE, THE STENT WAS INADVERTENTLY PARTIALLY DEPLOYED. THE STENT WAS NOT USED, AND A NEW STENT WAS IMPLANTED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735867 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT RESTENOSIS AND ISCHEMIA OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2023, THIS 6X40, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN AN ATHERECTOMY AND BALLOON ANGIOPLASTY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY, AND STENTING OF THE RIGHT SFA. ATHERECTOMY WAS PERFORMED TO DEBULK THE IN-STENT RESTENOSIS OF AN UNKNOWN STENT. REPEAT IMAGING SHOWED PERSISTENT RESIDUAL STENOSIS; THEREFORE, THIS STENT WAS DEPLOYED AT THE PROXIMAL END OF THE EXISTING STENT, OVERLAPPING APPROXIMATELY 5 MM. BALLOON ANGIOPLASTY WAS THEN PERFORMED TO THE DISTAL SFA AND ABOVE-KNEE POPLITEAL WITH A 5 X 200 MM BALLOON INFLATED FOR 3 MINUTES. FINAL IMAGING SHOWED AN EXCELLENT RESULT WITH NO SIGNIFICANT RESIDUAL STENOSIS, BRISK FLOW AND PRESERVED RUNOFF. ON (B)(6) 2024, SELECTIVE RIGHT LOWER EXTREMITY ARTERIOGRAM, ATHERECTOMY, BALLOON ANGIOPLASTY OF THE RIGHT SFA, PERCUTANEOUS MECHANICAL THROMBECTOMY OF THE RIGHT POPLITEAL ARTERY, AND INTRAVASCULAR ULTRASOUND WERE PERFORMED DUE TO PERIPHERAL ARTERY DISEASE WITH ACUTE LIMB THREATENING ISCHEMIA. IMAGING SHOWED THE PROXIMAL SFA WAS PATENT; HOWEVER, THE TWO OVERLAPPING STENTS WERE OCCLUD

  Patient problems: Ischemia; Restenosis; Thrombosis/Thrombus

  MAUDE report 18731994 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CRITICAL LIMB ISCHEMIA OF THE LEFT LOWER EXTREMITY OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE FIRST TARGET LESION WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO LEFT PROXIMAL POPLITEAL ARTERY WITH 5.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 40 MM WITH 80% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, LITHOTRIPSY WAS PERFORMED BY USING 5.0 MM X 60 MM NON-BOSTON SCIENTIFIC (BSC) LITHOTRIPSY DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 5.0 MM X 200 MM RANGER DRUG-COATED BALLOON. FOLLOWING POST TREATMENT WAS PERFORMED BY THE PLACEMENT OF 5.0 MM X 60 MM NON-BSC BARE METAL STENT, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. DURING THE TREATMENT OF THE FIRST TARGET LESION, DISSECTION OF GRADE B WAS NOTED DUE TO LITHOTRIPSY DEVICE WHICH WAS TREATED WITH PLACEMENT OF BARE METAL STENT. THE SECOND TARGET LESION WAS IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY WITH 5

  Patient problems: Ischemia; Restenosis; Ulcer

  MAUDE report 18087307 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OCCLUSION AND DISSECTIONS OCCURRED. ON (B)(6) 2023, BLOOD HAS DRAWN IN THE HOLDING AREA AND A CHEM 8 WAS PERFORMED TO EVALUATE THE PATIENT'S RENAL FUNCTION. THE CREATININE WAS 1.0. AFTER COUNSELING THE PATIENT FOR THE PROCEDURE, THE PATIENT WAS TAKEN TO THE FLUOROSCOPY SUITE AND PLACED IN THE SUPINE POSITION. THE BILATERAL GROINS WERE PREPPED END DRAPED IN THE USUAL MANNER. MONITORED MODERATE SEDATION WAS INSTITUTED WITH IV VERSED AND FENTANYL. ULTRASOUND GUIDANCE FOR VASCULAR ACCESS WAS USED TO DOCUMENT VESSEL PATENCY WITH CONCURRENT ULTRASOUND VISUALIZATION OF VASCULAR NEEDLE ENTRY WITH PERMANENT RECORDING AND REPORTING OF VESSEL PATENCY. UNDER ULTRASOUND GUIDANCE, THE SKIN AND SOFT TISSUES OVER THE LEFT COMMON FEMORAL ARTERY WERE INFILTRATED WITH 1% LIDOCAINE. UNDER ULTRASOUND GUIDANCE, THE LEFT COMMON FEMORAL ARTERY WAS ACCESSED WITH MICROPUNCTURE NEEDLE AND WIRE. A MICROPUNCTURE SHEATH WAS ADVANCED OVER THE WIRE. THE WIRE WAS UPSIZED TO AN 035 NON BOSTON SCIENTIFIC WIRE WHICH WAS ADVANCED INTO THE ABDOMINAL AORTA UNDER FLUOROSCOPIC GUIDANCE. A SHEATH EXCHANGE WAS THEN PERFORMED, PLACING A 5 FRENCH SHORT SHEATH. A FLUSH CATHETER WAS THEN ADVANCED OVER TH

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 17597137 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  S2444 ELEGANCE IT WAS REPORTED THAT THE SUBJECT EXPERIENCED IN-STENT RESTENOSIS 430 POST INDEX PROCEDURE. 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 TARGET LESION WAS IN RIGHT PROXIMAL AND MID SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING UP TO RIGHT DISTAL SFA. THE TARGET LESION HAD A PROXIMAL REFERENCE DIAMETER OF 6.0 MM, DISTAL REFERENCE VESSEL DIAMETER OF 6.0 MM, AND A LESION LENGTH OF 250 MM. THE TARGET LESION WAS 90% STENOSED AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATION WAS PERFORMED USING A 5 MM X 200 MM NON-BOSTON SCIENTIFIC BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 6 MM X 200 MM RANGER DRUG COATED BALLOON FOLLOWED BY PLACEMENT OF STUDY STENT, 6 MM X 40 MM, ELUVIA DRUG-ELUTING STENT. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON THE SAME DAY, DURING THE TREATMENT OF TARGET LESION, DISSECTION OF GRADE C WAS NOTED IN THE PROXIMAL SFA DUE TO RANGER DRUG COATED BALLOON. IN RESPONSE, ELUVIA DRUG ELUTING STENT WAS PLACED, AND THE COMPLICATION WAS RE

  Patient problems: Restenosis

  MAUDE report 17545194 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT THE STENT WAS OCCLUDED. 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 IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY WITH 6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 40 MM AND 80% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT USING STUDY DEVICE OF SIZE 6MM X 40 MM ELUVIA DRUG ELUTING STENT. FOLLOWING POST DILATATION WITH 6.0 MM X 40 MM MUSTANG PTA BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2022, SUBJECT WAS NOTED WITH THE SYMPTOMS RELATED TO RIGHT SFA OCCLUSION. ON (B)(6) 2022, SUBJECT VISITED THE HOSPITAL WITH COMPLAINTS OF WORSENING THROBBING PAIN IN THE RIGHT FOOT FROM PAST ONE MONTH AND RIGHT FOOT PAIN AT NIGHT AND WITH WALKING. ON THE SAME DAY, ANKLE TO BRACHIAL INDICES REVEALED 0.51 AND 0.97 ON RIGHT AND LEFT LEG RESPECTIVELY AND RUTHERFORD CATEGORY OF 4 REST PAIN CONSISTENT WITH CRITICAL RIGHT LIMB ISCHEMIA. BILATERAL LOWER EXTREM

  Patient problems: Obstruction/Occlusion

  MAUDE report 17266337 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG COATED BALLOON AND RANGER DRUG COATED BALLOON ON (B)(6) 2022. THE FIRST TARGET LESION WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT PROXIMAL POPLITEAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 40 MM AND 80 % STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, LITHOTRIPSY WAS PERFORMED WITH 5 MM X 60 MM NON-BOSTON SCIENTIFIC DEVICE. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION WITH STUDY DEVICE, RANGER DRUG-COATED BALLOON OF 5 MM X 200 MM. FOLLOWED BY PLACEMENT OF 5.0 MM X 60 MM NON-BOSTON SCIENTIFIC BARE METAL STENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%. THE SECOND TARGET LESION WAS IN THE LEFT MID SFA WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM WITH LESION LENGTH OF 120 MM AND 80 % STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE LITHOTRIPSY WAS PERFORMED WITH 5 MM X 60 MM NON-BOSTON SCIENTIF

  Patient problems: No Clinical Signs, Symptoms or Conditions; Restenosis

  MAUDE report 15135993 ↗
• MalfunctionJun 24, 2021Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE DEVICE BROKE. A 6X40X130 DRUG ELUTING SELF-EXPANDING STENT WAS SELECTED FOR USE IN A PERIPHERAL LEG INTERVENTION. DURING THE PROCEDURE, THE INNER LINER OF THE STENT SYSTEM DETACHED FROM THE REST OF THE DELIVERY SYSTEM. THE STENT WAS SUCCESSFULLY DELIVERED. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED, HOWEVER, IT WAS IN TWO PIECES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059194 ↗
• InjuryMar 11, 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 (SFA). THE TARGET LESION WAS 100MM LONG. DURING PREPARATION, THE PACKAGING WAS OPENED, AND THE DEVICE INSIDE WAS THE INCORRECT SIZE. THE PACKAGE WAS LABELED 6MM X 100MM, BUT THE STENT SIZE WAS DETERMINED TO BE 6MM X 40MM BY BALLOON COMPARISON. IT WAS NOTED THAT THE INNER POUCH MATCHED THE OUTER CARTON/SHELF CARTON. THE 6MM X 40MM STENT WAS IMPLANTED ANYWAY TO AVOID WASTE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11465824 ↗
• MalfunctionNov 6, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 6X40X130 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE FOR AN ANGIOPLASTY AND STENTING PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING PREPARATION, IT WAS OBSERVED THAT THE STENT WAS JUST BARELY EXPOSED AT THE TAPERED NOSE CONE AS IF IT WAS STARTING TO DEPLOY. HOWEVER, THE YELLOW SAFETY WAS STILL INTACT ON THE DEPLOYMENT WHEEL. THE STENT WAS NEVER INTRODUCED INTO THE SHEATH OR PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10800790 ↗
• MalfunctionOct 15, 2019Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT AN INADVERTENT DEPLOYMENT OCCURRED. A 6X40X130 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR A PERIPHERAL STENTING PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE DELIVERY SYSTEM WOULD NOT TRACK OVER THE NON-BSC GUIDEWIRE. IT WAS POSSIBLE THAT THE WIRE KINKED. THE ELUVIA DEVICE WAS REMOVED FROM THE PATIENT WITH THE STENT FULLY INTACT. THE YELLOW SAFETY TAB HAD BEEN REMOVED FROM THE THUMBWHEEL AND THE STENT WAS ACCIDENTALLY DEPLOYED ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. THE PATIENT WAS FINE AND THERE WERE NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9191458 ↗
• MalfunctionMar 20, 2019Difficult to Insert; Premature Activation; Difficult to Advance; Difficult to Insert; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 6X40X130 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION. DURING THE PROCEDURE, THE DEVICE WAS LOADED ON A .035, 180 CM GUIDEWIRE. THE ELUVIA DEVICE WAS NOT FLUSHED AND THE YELLOW STYLET WAS NOT REMOVED FROM THE BACK. WHILE LOADING ON THE WIRE, THE WIRE DID NOT COME OUT THE BACK. THE ELUVIA DEVICE WAS TAKEN OFF THE WIRE AND WAS NOT DEPLOYED. THE CLIP REMAINED ON. IT WAS NOTED THAT THE TIP WAS PARTIALLY DEPLOYED AFTER THE ELUVIA WAS TAKEN OFF THE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8437032 ↗