ELUVIA™ H74939294700610Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729876700), received between Nov 12, 2021 and Jan 30, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RESTENOSIS GUARANTEE PROGRAM IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THIS 7X60, 130 CM ELUVIA WAS SELECTED FOR USE IN AN ARTERIOGRAM WITH LEFT LEG REVASCULARIZATION PROCEDURE. DURING THE PROCEDURE, MULTIPLE WIRE AND CATHETER COMBINATIONS WERE USED TO CANNULATE THE OCCLUDED SUPERFICIAL FEMORAL ARTERY ORIGIN. AN UP AND OVER THROUGH AND THROUGH WIRE ACCESS APPROACH WAS OBTAINED FROM THE LEFT PEDAL TO THE RIGHT FEMORAL ACCESS SHEATHS. DUE TO LONG CHRONIC OCCLUSION WITH DENSE CALCIFICATION, A 2.5 MM ROTABLATOR DEVICE WAS USED TO PERFORM FEMORAL-POPLITEAL ATHERECTOMY. BALLOON ANGIOPLASTY WAS PERFORMED OF THE COMMON FEMORAL, SUPERFICIAL FEMORAL, AND POPLITEAL ARTERIES USING 6 MM PLAIN BALLOON. FOLLOW-UP ANGIOGRAM SHOWED RESTORED FLOW THROUGH THE FEMORAL AND POPLITEAL ARTERIES BUT WITH SEVERE RESIDUAL STENOSIS AND MULTIPLE AREAS OF FLOW-LIMITING DISSECTION. REPEAT BALLOON ANGIOPLASTY WAS PERFORMED WITH PROLONGED INFLATION BUT WITH PERSISTENT RESULTS. THIS WAS ADDRESSED WITH STENTING WITH FIVE ELUVIA STENTS WHICH ULTIMATELY REQUIRED EXTENSION FROM THE SUPERFICIAL FEMORAL ORIGIN DOWN TO THE POPLITEAL AT THE KNEE STENTS. BALLOON ANGIOPLASTY W

  Patient problems: Pain; Restenosis; Thrombosis/Thrombus

  MAUDE report 21277608 ↗
• InjuryJan 15, 2025Adverse 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 THE ELUVIA DRUG ELUTING STENT ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING UP TO RIGHT PROXIMAL POPLITEAL ARTERY WITH 7 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 7 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH OF 40 MM AND 90% STENOSIS AND WAS CLASSIFIED AS TASC II A LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH STUDY DEVICE, BALLOON DILATION WAS PERFORMED USING A 6.5 MM X 40 MM NON-BOSTON SCIENTIFIC BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF A 7 MM X 60 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING TREATMENT, POST-DILATION WAS PERFORMED USING A 7 MM X 20 MM NON-BOSTON SCIENTIFIC BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2024, THE SUBJECT VISITED THE HOSPITAL FOR FOLLOW UP AND WAS NOTED TO HAVE DEVELOPED A WOUND ON THE POSTERIOR CALF OF THE RIGHT LEG WITH CLAUDICATION. ON THE SAME DAY, THE ARTERIAL EXAMINATION OF LOW

  Patient problems: Arteriosclerosis/ Atherosclerosis; Restenosis; Unspecified Tissue Injury

  MAUDE report 21164038 ↗
• InjuryApr 30, 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, REQUIRING INTERVENTION. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH THIS 7X60, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE 90% STENOSED TARGET LESION WAS IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), EXTENDING UP TO THE RIGHT PROXIMAL POPLITEAL ARTERY, WITH 7 MM PROXIMAL REFERENCE VESSEL DIAMETER, AND 7 MM DISTAL REFERENCE VESSEL DIAMETER, WITH LESION LENGTH OF 40 MM. THE LESION WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II A LESION. PRIOR TO THE TREATMENT OF THE TARGET LESION WITH THE STUDY DEVICE, BALLOON DILATION WAS PERFORMED USING A 6.5 MM X 40 MM NON-BOSTON SCIENTIFIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. TREATMENT OF THE TARGET LESION WAS THEN PERFORMED BY PLACEMENT OF THIS 7 MM X 60 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING TREATMENT, POST-DILATION WAS PERFORMED USING 7 MM X 20 MM NON-BOSTON SCIENTIFIC PTA BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON CLOPIDOGREL. ON (B)(6) 2024, THE SUBJECT VISIT

  Patient problems: Numbness; Pain; Paresthesia; Restenosis

  MAUDE report 19217518 ↗
• MalfunctionJan 31, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE INNER PACKAGING SEAL WAS OPEN. THE BOX CONTAINING THIS 7X60, 130CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS OPENED AND IT WAS FOUND THAT THE INNER PACKAGING SEAL WAS OPEN. THE STENT WAS NOT USED AND A NEW STENT WAS ABLE TO BE USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616945 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT THE SUBJECT EXPERIENCED STENT THROMBOSIS AND STENT UNDER EXPANSION DURING THE INDEX PROCEDURE. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENTS AND RANGER DRUG-COATED BALLOON ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION (001) WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA, LEFT DISTAL SFA, LEFT PROXIMAL POPLITEAL ARTERY, EXTENDING UP TO LEFT MID POPLITEAL ARTERY. THE TARGET LESION HAD A 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 70% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 4 MM X 220 MM AND 6 MM X 120 MM STERLING OVER THE WIRE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICES, PLACEMENT OF TWO 7 MM X 120 MM, ONE 7 MM X 60 MM, AND ONE 7 MM X 80 MM ELUVIA DRUG-ELUTING STENTS, FOLLOWED BY 6 MM X 120 MM RANGER DRUG-COATED BALLOON ANGIOPLASTY. FOLLOWING WHICH, POST-TREATMENT WAS PERFORMED WITH PLACEMENT OF A 7 MM X 250 MM NON-BOSTON SCIENTIFIC STENT AND BALLOON DILATION WAS PERFORMED BY USING A 6 MM X 60 MM NON-BOSTON SCIENTIFIC BALLOON, 7 MM

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17842907 ↗
• MalfunctionSep 14, 2023Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. THIS 7X60, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A RUNOFF PROCEDURE FOR PERIPHERAL ARTERY DISEASE. THE STENT SYSTEM WAS LOADED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE. AS SOON AS THE STENT WAS LOADED ON THE WIRE, IT WAS DIFFICULT TO ADVANCE; THEREFORE, THE STENT SYSTEM WAS REMOVED FROM THE WIRE. HOWEVER, WHEN PULLING IT OFF THE WIRE THE STENT INADVERTENTLY DEPLOYED. IT WAS NOTED THAT THE STENT NEVER ENTERED THE PATIENTS BODY. THE PROCEDURE WAS COMPLETED WITH A NEW STENT AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745131 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT IN-STENT OCCLUSION 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 IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 6.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND A 6.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 50 MM WITH 95% STENOSIS AND WAS CLASSIFIED AS A TASC II A LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED WITH A 5.0 MM X 40 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF STUDY DEVICE: 7 MM X 60 MM ELUVIA DRUG-ELUTING STENT. POST-DILATION WAS PERFORMED WITH A 7.0 MM X 40 MM MUSTANG OTW PTA BALLOON, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2022, DURING STUDY SPECIFIC 12-MONTH FOLLOW UP VISIT, RIGHT LOWER EXTREMITY ARTERIAL DUPLEX WAS PERFORMED WHICH REVEALED OCCLUDED STENT FROM RIGHT PROXIMAL SFA TO RIGHT MID SFA WITH RE-CONSTITUTION IN THE RIGHT DISTAL SFA AND 20-49% STENOSIS IN RIGHT PROFUNDA FEMORIS ARTERY. BASED ON THESE FI

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Pain

  MAUDE report 17686760 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL TRIAL. IT WAS REPORTED THAT 13 DAYS POST-INDEX THE PATIENT HAD BILATERAL WORSENING LIMB ISCHEMIA AND STENT OCCLUSION. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG ELUTING STENTS ON (B)(6) 2022 AS A PART OF THE (B)(6) CLINICAL TRIAL. THE TARGET LESION WAS IN LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), MID SFA AND MID POPLITEAL ARTERY. THE LESION HAD A 6.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.0 MM DISTAL REFERENCE VESSEL DIAMETER, WHICH A TOTAL LESION LENGTH OF 420 MM AND 99% STENOSIS AND CLASSIFIED AS TASC II LESION. PRIOR TO TARGET LESION TREATMENT, BALLOON DILATION WAS PERFORMED WITH 4.0 X 120 MM AND 5.0 X 80 MM CHARGER PTA BALLOONS. TREATMENT OF TARGET LESION WAS PERFORMED BY PLACEMENT OF STUDY DEVICE, ELUVIA DRUG ELUTING STENTS OF SIZES 6 MM X 120 MM, 7 MM X 60 MM, 7 MM X 120 MM AND 7 MM X 120 MM. POST TREATMENT OF TARGET LESION, DILATATION WAS PERFORMED WITH 4.0 MM X 60 MM, 4.0 MM X 200 MM, 5.0 MM X 60 MM, 5.0 MM X 120 MM AND 6.0 MM X 150 MM CHARGER PTA BALLOONS AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2022, SUBJECT WAS DISCHARGED FROM HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2022, 13 DAYS POST INDEX PROCEDURE, SUB

  Patient problems: Ischemia; Obstruction/Occlusion; Pain

  MAUDE report 14591257 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION OCCURRED IN THE RIGHT EXTERNAL ILIAC. A 9MM X 40MM EPIC STENT, A 7MM X 60MM ELUVIA STENT AND 7MM X 40MM MUSTANG WERE SELECTED FOR THE TREATMENT OF PERIPHERAL VASCULAR DISEASE IN THE EXTERNAL ILIAC. THE LESION WAS PRE-DILATED WITH A 5MM X 100MM MUSTANG BALLOON FOLLOWED BY AN ARTERIOGRAM TO MARK THE LANDING ZONES. A 9MM X 40MM EPIC STENT AND A 7MM X 60MM ELUVIA STENT WERE PLACED TO TREAT THE LESION. POST DILATION WAS PERFORMED WITH A 7MM X 40MM MUSTANG. THE CERTIFIED RN ANESTHETIST NOTICED CHANGES IN THE PATIENT'S CARBON DIOXIDE LEVELS AND BLOOD PRESSURE. REPEAT ARTERIOGRAMS WERE PERFORMED REVELING A PERFORATION IN THE RIGHT EXTERNAL ILIAC. HYPOTENSION AND BLOOD LOSS WERE REPORTED AS A RESULT OF THE PERFORATION. IT WAS THOUGHT THAT THE PERFORATION POSSIBLY OCCURRED DURING POST DILATION OF THE STENTS AND CALCIFICATION OF THE LESION CONTRIBUTED TO THE PERFORATION. THE PERFORATION WAS TREATED USING A NON-BOSTON SCIENTIFIC STENT AND MULTIPLE LONG BALLOON INFLATIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AFTER THE PERFORATION WAS TREATED. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 12802593 ↗