ELUVIA™ H74939294600610Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729876588), received between Mar 8, 2019 and Sep 29, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that occlusion occurred, requiring additional intervention.The subject underwent treatment with the Ranger Drug Coated Balloon and Eluvia Drug eluting stent on (b)(6) 2025 as a part of the clinical trial. The subject underwent treatment with the Ranger Drug Coated Balloon and Eluvia Drug eluting stent on (b)(6) 2025 as a part of a clinical trial. The target lesion #001 was in the left proximal superficial femoral artery, left mid superficial femoral artery extending up to left distal superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 175 mm lesion length with 100% stenosis and was classified as TransAtlantic InterSociety Consensus (TASC) II C lesion. Prior to the target lesion treatment with the study device, lithotripsy was performed using 6 mm x 80 mm Shockwave E8 IVL lithotripasy device and pre-dilation was performed using 6 mm x 200 mm Sterling OTW PTA balloon. Treatment of target lesion was performed by dilation using 6 mm x 200 mm Ranger Drug-Coated Balloon study device and placement of 6 mm x 60 mm and 6 mm x 150 mm ELUVIA Drug-Eluting Stent, study devices. Following post dilation was perform

  Patient problems: Obstruction/Occlusion

  MAUDE report 50933065 ↗
• MalfunctionFeb 24, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 6X60, 130 CM ELUVIA WAS SELECTED FOR USE. DURING ADVANCEMENT OVER THE .035 GUIDEWIRE, THE CLIP ON THE WHEEL WAS STILL ATTACHED, BUT THE STENT DEPLOYED 2MM. THE STENT NEVER WENT INTO THE PATIENT. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21449736 ↗
• InjuryJun 27, 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 AN ARTERIOGRAM WITH RIGHT LEG REVASCULARIZATION. WIRE AND CATHETER TAKEN DOWN THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES WITH SELECTIVE ANGIOGRAPHY AT EACH LEVEL. SUPERFICIAL FEMORAL-POPLITEAL OCCLUSION CROSSED, AND CATHETER TAKEN DOWN THE LEVEL OF PATENT DISTAL POPLITEAL LUMEN. ATHERECTOMY WAS PERFORMED IN THE SUPERFICIAL FEMORAL AND POPLITEAL OCCLUSIONS WITH A 2.0 MM ROTABLATOR. THEN ANGIOPLASTY WAS PERFORMED USING A 5MM PLAIN BALLOON. FOLLOW-UP ANGIOGRAM SHOWED SEGMENT OF SIGNIFICANT LUMINAL IRREGULARITY IN SEVERE RESIDUAL STENOSIS THEREFORE THIS PORTION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WAS STENTED USING A 6 X 60 MM ELUVIA DRUG-ELUTING OPEN CELL SELF-EXPANDING STENT. THIS WAS POST-DILATED USING A 5 MM BALLOON WHICH WAS OVEREXPANDED. COMPLETION ANGIOGRAM PERFORMED. CATHETER AND SHEATH AND WIRE REMOVED. GOOD RESULT. PALPABLE PEDAL PULSES PRESENT POST INTERVENTION. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ARTERIOGRAM WITH RIGHT LEG REVASCULARIZATION. WIRE AND CATHETER TAKEN DOWN THE RIGHT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES WITH SELECTIVE ANGIOGRAPHY PERFORMED AT EACH LE

  Patient problems: Obstruction/Occlusion

  MAUDE report 19625326 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL STUDY: IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG-COATED BALLOONS AND AN ELUVIA DRUG-ELUTING STENT ON (B)(6) 2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT PROXIMAL EXTENDING UP TO DISTAL POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 190 MM AND 100% STENOSIS. IT WAS CLASSIFIED AS A TASC II C LESION. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICE, 4.0 MM NON-BOSTON SCIENTIFIC EMBOLIZATION PROTECTION DEVICE WAS USED AND PRE DILATION WAS PERFORMED BY USING 5 MM X 150 MM AND 4 MM X 40 MM NON-BOSTON SCIENTIFIC BALLOONS. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICES OF SIZES 4 MM X 40 MM, 5 MM X 200 MM, AND 5 MM X 60 MM RANGER DRUG-COATED BALLOONS FOLLOWED BY PLACEMENT OF STUDY DEVICE 6 MM X 60 MM ELUVIA DRUG-ELUTING STENT. POST DILATION WAS PERFORMED USING 5 MM X 20 MM NC EMERGE PTCA DILATION CATHETER, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL A

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

  MAUDE report 18946299 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCAPACITATION CLAUDICATION OF THE LEFT LEG AS A RESULT OF IN-STENT REOCCLUSION. AN ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE TO TREAT A CASE OF PERIPHERAL VASCULAR DISEASE WITH BILATERAL LOWER EXTREMITY CLAUDICATION. WITH THE PATIENT IN THE SUPINE POSITION ON FLUOROSCOPIC TABLE, BOTH GROINS WERE PREPPED AND DRAPED IN USUAL FASHION. 1% XYLOCAINE WITHOUT EPINEPHRINE WAS USED FOR LOCAL INFILTRATIVE ANESTHESIA. PATIENT WAS GIVEN VERSED AND FENTANYL INTRAVENOUSLY IN SMALL INCREMENTS THROUGH THE COURSE OF THE PROCEDURE FOR COMFORT. THE PATIENT WAS ALSO GIVEN INTRA-ARTERIAL NITROGLYCERIN THROUGH THE COURSE OF THE PROCEDURE FOR HYPERTENSION AND TO PREVENT VASOSPASM. THE PATIENT WAS GIVEN HYDRALAZINE ALSO FOR HYPERTENSION. THE SITE RIGHT ULTRASOUND WAS USED FOR REAL-TIME IMAGING FOR NEEDLE ENTRY INTO THE RIGHT COMMON FEMORAL ARTERY WITH PHOTOGRAPHIC DOCUMENTATION. A 21-GAUGE MICRO PUNCTURE NEEDLE WAS USED, AND A 0.018 WIRE WAS PASSED FOLLOWED BY A 4 FRENCH INTRODUCER. A J-WIRE WAS PASSED TO THE SUPRARENAL AORTA AND A 5 FRENCH SHEATH WAS PLACED. A NON-BOSTON SCIENTIFIC CATHETER WAS PASSED TO THE LEVEL OF L1 AND ABDOMINAL AORT

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion; Pain; Vasoconstriction

  MAUDE report 18246862 ↗
• MalfunctionJul 8, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A PARTIAL DEPLOYMENT OCCURRED. A 6 X 60 X130 CM ELUVIA SELF EXPANDING STENT WAS SELECTED FOR THE TREATMENT OF PERIPHERAL ARTERIAL DISEASE IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS SEVERELY CALCIFIED. AFTER THE LESION WAS PRE-DILATED, THE ELUVIA STENT WAS INTRODUCED CONTRALATERALLY. ADVANCING THE DEVICE REQUIRED FORCE AND IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED EVEN WITH THE GUARD IN PLACE. THE STENT WAS DEPLOYED A COUPLE MILLIMETERS. THE STENT WAS FULLY CONSTRAINED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958380 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT CLAUDICATION AND OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH RANGER DRUG COATED BALLOONS (DCB) AND ELUVIA DRUG ELUTING STENT ON (B)(6) 2022 AS PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT PROXIMAL POPLITEAL ARTERY, MID POPLITEAL ARTERY EXTENDING TO DISTAL POPLITEAL ARTERY. THE LESION HAD A PROXIMAL REFERENCE VESSEL DIAMETER OF 5MM, DISTAL REFERENCE VESSEL DIAMETER OF 5MM, LESION LENGTH OF 190MM, 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO TARGET LESION TREATMENT, A NON BOSTON SCIENTIFIC (BSC) EMBOLIZATION PROTECTION DEVICE WAS USED AND PRE DILATION WAS PERFORMED WITH A 5MM X 150MM AND 4MM X 40MM NON-BSC BALLOONS. TREATMENT OF TARGET LESION WAS PERFORMED BY THE FOLLOWING RANGER DCB STUDY DEVICES: 4MM X 40MM, 5MM X 200MM AND 5MM X 60MM, RESPECTIVELY, FOLLOWED BY PLACEMENT OF A 6MM X 60MM ELUVIA DRUG ELUTING STUDY STENT. FOLLOWING POST DILATION WITH 5MM X 20MM NC EMERGE BALLOON, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 30%. ON (B)(6) 2022, THE SUBJECT VISITED THE HOSPITAL WITH SYMPTOMS RELATED TO CLAUDICATION. SEGMENTAL PRESSU

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

  MAUDE report 14639325 ↗
• MalfunctionApr 26, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. VASCULAR ACCESS WAS GAINED VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6X60, 130CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. DURING INSERTION, THE STENT BEGAN TO DEPLOY IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214678 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS AND OCCLUSION OCCURRED. ON (B)(6) 2021, FOLLOWING AN ATHERECTOMY PROCEDURE, IMAGING SHOWED A PATENT BUT SMALL FLOW CHANNEL IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). BALLOON ANGIOPLASTY WAS PERFORMED TO THE ENTIRE SFA WITH A 5 X 250 MM BALLOON INFLATED TO FULL PROFILE FOR 3 MINUTES USING 2 OVERLAPPING INFLATIONS. REPEAT IMAGING SHOWED A GOOD RESULT WITH THE EXCEPTION OF A SIGNIFICANT RESIDUAL STENOSIS AT THE LEVEL OF THE DISTAL OCCLUSION CAP. AN ADDITIONAL 5 MINUTE INFLATION WAS PERFORMED WITH THE 5 MM BALLOON. NO SIGNIFICANT IMPROVEMENT WAS SEEN DURING REPEAT IMAGING. THEREFORE, A 6X60, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED TO BE DEPLOYED IN THE LEFT SFA IN STANDARD FASHION. FINAL IMAGING OF THE TARGET LESION SHOWED NO SIGNIFICANT RESIDUAL STENOSIS, BRISK FLOW THROUGH THE FEMORAL-POPLITEAL SYSTEM AND PRESERVED RUNOFF. THE PATIENT TOLERATED THE PROCEDURE AND WAS TAKEN TO RECOVERY IN GOOD CONDITION. ON (B)(6) 2022, DURING INDEX PROCEDURE, IT WAS NOTED THAT THE SUPERFICIAL FEMORAL ARTERY WAS OCCLUDED AT ITS ORIGIN. USING ROADMAP IMAGING, A NON-BOSTON SCIENTIFIC GUIDEWIRE AND A RUBICON CROSSING CATHETER WERE ADVANCED THROUGH T

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 13933297 ↗
• InjuryMay 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE DEVICE CAME OFF IN THE PATIENT AN HAD TO BE SNARED TO REMOVE. A 6X60X130 ELUVIA SELF-EXPANDING DRUG ELUTING STENT WAS SELECTED FOR USE IN A PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE ELUVIA CATHETER CAME OFF IN THE PATIENT. THE PHYSICIAN SNARED THE DEVICE. THE PATIENT WAS REPORTED AS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884502 ↗
• MalfunctionAug 14, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 6 X 60 X 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. ANGIOPLASTY WAS PERFORMED PRIOR TO STENT PLACEMENT. TWO ELUVIA 6 X 120 STENTS WERE PLACED SUCCESSFULLY OVER A NON-BSC GUIDEWIRE. THE GUIDEWIRE HAD A SLIGHT KINK. IN AN ATTEMPT TO LOAD THE 6 X 6 X 130 ELUVIA STENT OVER THE GUIDEWIRE PAST THE KINK LOCATION, THE STENT BEGAN TO DEPLOY OVER THE WIRE PRIOR TO ADVANCING THROUGH THE SHEATH. THE LOCK WAS NEVER TAKEN OFF OF THE THUMBWHEEL. THE THUMBWHEEL NOR THE PULL GRIP WERE USED. THE STENT WAS STILL OUTSIDE THE PATIENTS BODY AND NEVER ENTERED THE PATIENT. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE GUIDEWIRE WITHOUT INCIDENCE. THE KINKED WIRE WAS REPLACED WITH A NEW WIRE AND THE PROCEDURE WAS COMPLETED WITH A 6 X 40 ELUVIA STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10408228 ↗
• InjuryMar 8, 2019Difficult or Delayed Positioning; Material Deformation; Migration; Difficult or Delayed Positioning; Material Deformation; Migration

  IT WAS REPORTED THAT STENT DAMAGE AND MIGRATION OCCURRED. A 6X60 ELUVIA WAS SELECTED TO TREAT A LESION LOCATED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). DURING STENT DEPLOYMENT, THE CATHETER SHEATH CAUGHT THE STENT AND PULLED THE STENT BACKWARDS PROXIMALLY. THE STENT ELONGATED AS A RESULT. THE STENT WAS DEPLOYED; HOWEVER, IN A MORE PROXIMAL LOCATION THAN INTENDED. A LONG SHEATH WAS ADVANCED THROUGH THE ELUVIA STENT WHICH CAUSED THE ELUVIA TO MOVE SLIGHTLY. A 7X80 INNOVA WAS THEN DEPLOYED TO "SMOOTH OUT" THE ELUVIA STENT AND CONNECT IT TO A PREVIOUSLY DEPLOYED STENT IN THE SFA. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION REPORTED THAT THERE WERE NO ISSUES WITH THE DEPLOYMENT MECHANISM. THE PHYSICIAN WENT UP AND OVER USING A 7F SHEATH. THE DEGREE OF TORTUOSITY AND CALCIFICATION WAS MINOR. THE LESION WAS 100% STENOSED. PRIOR TO THE ELUVIA BEING USED, ATHRECTOMY AND POBA WERE PERFORMED RESULTING IN 50-70% RESIDUAL STENOSIS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8404798 ↗