ELUVIA™ H74939294601510Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 08714729876625), received between Dec 1, 2022 and Apr 27, 2026 — classified as 24 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (32 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT AND STENT STRETCHING OCCURRED. A 6X150, 130 CM ELUVIA SELF-EXPANDING STENT WAS SELECTED FOR A LEG ANGIOGRAM FOR PERIPHERAL ARTERY DISEASE VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS IN A NON-TORTUOUS AND MILDLY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY. DURING DEPLOYMENT, THE STENT DEPLOYED APPROXIMATELY 2 TO 3 CM, AND THEN DEPLOYMENT STOPPED. THE WHEEL AND PULL HANDLE WERE ATTEMPTED BUT WOULD NOT WORK. THE STENT WAS WITHDRAWN PARTIALLY DEPLOYED, CAUSING IT TO STRETCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008463 ↗
• MalfunctionFeb 5, 2026Fracture; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT FRACTURED OCCURRED. THE PATIENT WAS BEING TREATED FOR CHRONIC TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS 100% STENOSED, MILDLY TORTUOUS AND SEVERELY CALCIFIED. DURING THE PROCEDURE, PRE-DILATION WAS PERFORMED USING SEVERAL DIFFERENT SIZED BALLOONS AND ATHERECTOMY; BUT STENOSIS WAS REDUCED ONLY TO 80%. THE PHYSICIAN WAS ABLE TO PLACE AN .035 AMPLATZ SUPERSTIFF GUIDEWIRE AND ADVANCED A 6X150, 130 CM ELUVIA SELF-EXPANDING STENT. THE FIRST STENT WAS UNABLE TO CROSS THE LESION. A SECOND 6X150, 130 CM ELUVIA WAS THEN ADVANCED AND ABLE TO BE PLACED IN THE MID PORTION OF THE SFA. DURING DEPLOYMENT IT WAS OBSERVED THAT THE STENT HAD FRACTURED IN THE DISTAL PORTION. DEPLOYMENT WAS STOPPED AND THE PHYSICIAN USED A PIN AND PULL METHOD OVER THE .035 AMPLATZ TO REMOVE THE CATHETER WITH THE REMAINING PORTION OF THE STENT STILL ENCAPSULATED. THERE WAS NO CATHETER KINKS OBSERVED BUT THE REMOVED PORTION OF THE STENT WAS STRETCHED. THE FRACTURED PORTION REMAINED IN THE MID SFA. THE PHYSICIAN DOES NOT PLAN TO SURGICALLY REMOVE THE FRACTURED STENT. A SURGICAL BYPASS WILL BE PERFORMED IF THE PATIENT RECOVERS WELL FROM THE ENDOVASCULAR PROCEDURE. TH

  Patient problems: Foreign Body In Patient

  MAUDE report 24273583 ↗
• InjuryDec 22, 2025Entrapment of Device; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Positioning Problem; Entrapment of Device; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED THAT STENT DAMAGE AND STENT MALPOSITION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY VIA CONTRALATERAL APPROACH. A 6FR CONTRALATERAL SHEATH WAS PLACED INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). MULTIPLE WIRES WERE USED TO CROSS THE CHRONIC TOTAL OCCLUSION (CTO) OF THE SFA. A 4X220 STERLING WAS USED TO PRE DILATE. THE LESION WAS 50% STENOSED AFTER PREDILATION. A 6X150,130CM ELUVIA WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS ADVANCED TO THE DISTAL SFA AND UPON DEPLOYMENT, IT WAS NOTED THAT THE WHEEL STOPPED ADVANCING. ATTEMPTS TO FURTHER DEPLOY, THE STENT, WERE MADE BY USING THE GRIP HANDLE AND PULLING THE DEVICE. HOWEVER, AS A RESULT, THE STENT ELONGATED 380CM AND WAS DEPLOYED IN THE WRONG LOCATION. THE DEVICE AND 300CM V18 WIRE WERE REMOVED TOGETHER AS THE WIRE WAS STUCK. MULTIPLE STENTS WERE DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863736 ↗
• MalfunctionDec 8, 2025Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED, AND THE STENT FRACTURED DURING REMOVAL, RESULTING IN A CANCELLED PROCEDURE. A 6X150, 130 CM ELUVIA DRUG-ELUTING SELF-EXPANDING STENT WAS SELECTED FOR USE IN A TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT PARTIALLY DEPLOYED AND WOULD NOT FULLY DEPLOY. SINCE THE DEPLOYED PART OF THE STENT COULD NOT BE RECAPTURED, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, BUT THE STENT BEGAN TO FRACTURE. THE STENT, THE DEPLOYMENT SYSTEM, AND THE ACCESS SHEATH WERE REMOVED TOGETHER. MANUAL PRESSURE WAS APPLIED TO THE ACCESS SITE. THE ACCESS SITE WAS COMPROMISED, SO THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745757 ↗
• MalfunctionDec 3, 2025Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED, AND THE STENT STRETCHED. THE 30% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY AND ACCESSED VIA ANTEGRADE APPROACH. A 6MM X 150MM ,130CM ELUVIA? SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, ONLY 95% (APPROXIMATELY 145MM) OF THE STENT WAS DEPLOYED, AND THE FINAL 5MM OF THE STENT COULD NOT BE DEPLOYED. THE PULL GRIP WOULD NOT WORK, SO THE STENT WAS MANUALLY DEPLOYED BY BREAKING OPEN THE HANDLE AND PULLING THE CATHETER. THE STENT WAS IMPLANTED BUT STRETCHED SOME. THE DELIVERY CATHETER WAS REMOVED, A MUSTANG BALLOON CATHETER WAS USED TO POST DILATE, AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE PROCEDURE WAS PROLONGED, BUT THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711323 ↗
• InjuryNov 18, 2025Fracture; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Fracture; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT AND BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE APPROXIMATELY 20-30% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MILDLY CALCIFIED VESSEL VIA CONTRALATERAL APPROACH. A 6X150,130CM ELUVIA WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY ADVANCED OVER A .014 WIRE AND 80-90% OF THE STENT WAS DEPLOYED INSIDE A PREVIOUSLY PLACED 6X150 ELUVIA STENT. DURING THE END OF DEPLOYMENT, THE PHYSICIAN PINED AND PULLED THE BLUE PLUNGER AND THE LAST PART OF THE STENT REMAINED INSIDE THE ELUVIA DEPLOYMENT SHAFT. THE HANDLE WAS THEN SPLIT IN TWO AND THE PHYSICIAN TRIED TO PIN THE GOLD WIRE OF THE DEVICE AND PULL THE SILVER PART, AND IT WOULD STILL NOT DEPLOY. THE PHYSICIAN THEN PULLED THE STENT BACK INTO THE SHEATH, WHICH ENDED UP STRETCHING APPROXIMATELY 50-100MM OF THE ELUVIA STENT. THE STENT BROKE AND MOST OF THE STENT WAS INSIDE THE SHEATH. THE REMAINING 120MM OF THE STENT WAS DEPLOYED INSIDE THE PATIENT. A RUBICON WAS PLACED, AND THE WIRE WAS ABLE TO BE EXCHANGED FOR A .035 WIRE. THE SHEATH WAS THEN REMOVED, AND A NEW SHEATH WAS PLACED. A 6X200 CHARGER BALLOON WAS USED TO PREDILATE THE ENTIRE SUPERFICIAL FE

  Patient problems: Foreign Body In Patient

  MAUDE report 23582819 ↗
• InjurySep 18, 2025Fracture; Nonstandard Device; Failure to Advance; Activation, Positioning or Separation Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Nonstandard Device; Failure to Advance; Activation, Positioning or Separation Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND FRACTURED WITHIN THE PATIENT, AND AN ADDITIONAL STENT WAS REQUIRED TO TREAT THE LESION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). A 6X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE TO TREAT PERIPHERAL ARTERY DISEASE. DURING THE PROCEDURE, THE LESION WAS PREDILATED, AND THE STENT WAS ADVANCED. DIFFICULTY CROSSING THE LESION WAS NOTED. WHEN DEPLOYMENT WAS ATTEMPTED, ONLY ABOUT 3CM OF THE STENT DEPLOYED. THE REMAINDER OF THE STENT WOULD NOT DEPLOY. THE THUMBWHEEL STOPPED WORKING, SO THE PHYSICIAN ATTEMPTED TO PULL THE HANDLE AND UPON PULLING BACK THE PULL GRIP, THE STENT SNAPPED AND THE HANDLE ALSO SNAPPED. THE REMAINING PORTION OF THE STENT WAS REMOVED. AN ADDITIONAL OF TWO ELUVIA OF THE SAME SIZE AND A NON-BOSTON SCIENTIFIC STENT WAS IMPLANTED AT THE SITE OF THE FRACTURED STENT TO COVER THE PORTION OF THE STENT THAT BROKE OFF. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086407 ↗
• InjuryJul 8, 2025Activation, Positioning or Separation Problem; Device-Device Incompatibility; Material Deformation; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE STENT ELONGATED, AND AN ADDITIONAL DEVICE WAS REQUIRED. AN ELUVIA? WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT A CASE OF CHRONIC TOTAL OCCLUSION (CTO). THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 100% STENOSED. THE WIRE CROSSED EASILY. A THROMBECTOMY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC (BSC) MECHANICAL THROMBECTOMY DEVICE, WITH A NON-BSC EMBOLIC PROTECTION DEVICE PLACED DISTALLY WITHIN THE POPLITEAL ARTERY. AN UNKNOWN 5MM BALLOON WAS USED TO PRE-DILATE THE LESION, PRIOR TO THE DELIVERY OF THE ELUVIA STENT. APPROXIMATELY 30% OF THE STENT WAS DEPLOYED WHEN IT STOPPED DEPLOYING. THE DELIVERY CATHETER WAS PULLED, WHICH CAUSED THE STENT TO ELONGATE. THE PHYSICIAN REQUESTED SOME PACEMAKER INSTRUMENTS AND CRACKED THE DELIVERY HANDLE OPEN TO FULLY DEPLOY THE STENT. THE PHYSICIAN AND STAFF REPORTED THAT THE NON-BSC EMBOLIC PROTECTION DEVICE WAS TANGLED UP WITHIN THE ELUVIA DELIVERY HANDLE. AS A RESULT, THE NON-BSC EMBOLIC PROTECTION DEVICE AND ELUVIA DELIVERY SYSTEM WERE REMOVED TOGETHER. A SECOND ELUVIA STENT WAS PLACED PROXIMALLY TO THE INITIAL STENT IN ORDER TO FULLY TREAT THE LESION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437237 ↗
• InjuryJun 5, 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) 2023, THE SUBJECT UNDERWENT TREATMENT WITH THIS ELUVIA DRUG ELUTING STENT AS A PART OF A CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA, AND LEFT DISTAL SFA, WITH 5.2 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.2 MM DISTAL REFERENCE VESSEL DIAMETER WITH 20 MM LESION LENGTH WITH 100% STENOSIS. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT OF 7 MM X 150 MM ELUVIA DRUG ELUTING STENT AND DILATION USING 6 MM X 150 MM RANGER DRUG COATED BALLOON, STUDY DEVICES. FOLLOWING TREATMENT WAS PERFORMED BY PLACEMENT OF 6 MM X 150 MM ELUVIA DRUG ELUTING STENT AND 6 MM X 60 MM NON-BOSTON SCIENTIFIC DRUG ELUTING STENT. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2025 OCCLUSION NOTED IN THE LEFT COMMON FEMORAL ARTERY AND STENOSIS NOTED IN THE LEFT PROXIMAL SFA AND WERE ACCESSED BY LONGITUDINAL ARTERIOTOMY FROM THE LEFT COMMON FEMORAL ARTERY TO PROXIMAL SFA. FOLLOWED BY ENDARTERECTOMY WAS PERFORMED AND ARTERIOTOMY WAS CLOSED WITH BOV

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

  MAUDE report 22149709 ↗
• InjuryMay 28, 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) 2023, THE SUBJECT UNDERWENT TREATMENT WITH THIS ELUVIA DRUG ELUTING STENT AS A PART OF A CLINICAL TRIAL. THE TARGET LESION #001 WAS IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT DISTAL SFA, WITH 5.2 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 5.2 MM DISTAL REFERENCE VESSEL DIAMETER WITH 20 MM LESION LENGTH WITH 100% STENOSIS. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT OF 7 MM X 150 MM ELUVIA DRUG ELUTING STENT AND DILATION USING 6 MM X 150 MM RANGER DRUG COATED BALLOON, STUDY DEVICES. FOLLOWING TREATMENT WAS PERFORMED BY PLACEMENT OF 6 MM X 150 MM ELUVIA DRUG ELUTING STENT AND 6 MM X 60 MM NON-BOSTON SCIENTIFIC DRUG ELUTING STENT. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2024, THE SUBJECT VISITED THE HOSPITAL FOR FOLLOW UP AND UNDERWENT BILATERAL LOWER EXTREMITY ARTERIAL DOPPLER ULTRASOUND WHICH REVEALED: LEFT LOWER EXTREMITY (TARGET LIMB) NEW PROBABLE IN-STENT RESTENOSIS THROUGHOUT THE SFA STENT, WITH MULTIFOCAL STENOSES LEADING TO A PATENT POPLITEAL ARTERY A

  Patient problems: Arteriosclerosis/ Atherosclerosis; Numbness; Restenosis

  MAUDE report 22100994 ↗
• InjuryMay 23, 2025Fracture; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Fracture; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT AND STENT FRACTURE OCCURRED REQUIRING INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA ANTEGRADE APPROACH USING A 6F SHORT SHEATH. THE CHRONIC TOTAL OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) INTO THE DISTAL POPLITEAL ARTERY. A NON-BOSTON SCIENTIFIC GUIDEWIRE AND A SUPPORT CATHETER WERE ADVANCED TO THE LESION SUCCESSFULLY. THE GUIDEWIRE WAS REMOVED AND REPLACED WITH A .035 NON-BOSTON SCIENTIFIC GUIDEWIRE. A 5MMX12MM .035 BALLOON WAS INFLATED IN THE POPLITEAL/DISTAL SFA AND AGAIN IN THE PROXIMAL SFA. THERE WAS FLOW THROUGH THE VESSEL AFTER THIS. A 6MMX150MMX130CM ELUVIA WAS PLACED IN THE DISTAL SFA AND POST-DILATED WITH THE 5MM BALLOON. ANOTHER 6MMX150MMX130CM ELUVIA WAS ADVANCED DISTAL TO THE LESION AND OVERLAPPING THE PREVIOUS STENT. THE PHYSICIAN BEGAN USING NORMAL FORCE TO TURN THE THUMB WHEEL TO UNSHEATH AND DEPLOY THE STENT. A POP WAS HEARD AFTER APPROXIMATELY 50MM OF THE STENT WAS DEPLOYED AND THE THUMB WHEEL KEPT TURNING, YET THE STENT NO LONGER DEPLOYED. THE PHYSICIAN PULLED THE PULL-GRIP ON THE BACK END OF THE STENT, BUT THE STENT DID NOT DEPLOY. THE PHYSICIAN ATTEMPTED TO PUL

  Patient problems: Vascular Dissection

  MAUDE report 22080556 ↗
• MalfunctionMay 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT MATERIAL DEFORMATION OCCURRED. A 6X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR THE PROCEDURE TO TREAT PERIPHERAL ARTERIAL DISEASE (PAD). THE STENT DEPLOYED AND APPEARED TO BE SHORTER THAN EXPECTED, APPROXIMATELY 6X120. THE PROCEDURE SUCCESSFULLY COMPLETED USING ORIGINAL METHOD AND DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971423 ↗
• InjuryMay 2, 2025Adverse 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) 2024, THE PATIENT UNDERWENT A SELECTIVE RIGHT LOWER EXTREMITY AORTOGRAM, ATHERECTOMY, BALLOON ANGIOPLASTY AND STENTING OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE RIGHT SFA WAS OCCLUDED WITH 100% STENOSIS FROM JUST DISTAL TO THE ORIGIN TO THE DISTAL THIGH. UNABLE TO CROSS ANTEGRADE. THEREFORE, RIGHT DPA ACCESS PERFORMED. THROUGH AND THROUGH WIRE ACCESS ACHIEVED. ROTABLATOR 2.0 MM ATHERECTOMY PERFORMED TO SFA, FOLLOWED BY 6 MM BALLOON ANGIOPLASTY. IVUS SHOWED FLOW-LIMITING DISSECTION IN THE PROXIMAL/MID SFA. THEREFORE, A 6 X 150 MM ELUVIA DRUG-ELUTING STENT PLACED WITH EXCELLENT RESULT, NO SIGNIFICANT RESIDUAL STENOSIS. 3 MM BALLOON ANGIOPLASTY TO RIGHT DP ACCESS SITE FOR HEMOSTASIS. EXCELLENT RESULT AT COMPLETION WITH BRISK FLOW TO FOOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE WITH A SELECTIVE RIGHT LOWER EXTREMITY ARTERIOGRAM, MECHANICAL THROMBECTOMY, BALLOON ANGIOPLASTY AND STENTING OF RIGHT SUPERFICIAL FEMORAL ARTERY; ATHERECTOMY AND BALLOON ANGIOPLASTY OF RIGHT POPLITEAL ARTERY. THE FEMOROPOPLITEAL PATHOL

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 21951528 ↗
• InjuryApr 2, 2025Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT AND INTERNAL DEVICE FRACTURE OCCURRED, AND ADDITIONAL INTERVENTION WAS REQUIRED. AN ELUVIA US, 6X150, 130 CM WAS SELECTED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A FEW MILLIMETERS OF THE STENT DEPLOYED, THE REMAINDER OF THE STENT WOULD NO LONGER UNSHEATHE. THE PHYSICIAN ATTEMPTED TO PIN THE WHITE HANDLE AND PULL THE BLUE PLUNGER, BUT THE STENT STILL DID NOT DEPLOY FULLY. THE PHYSICIAN WAS ABLE TO PULL THE STENT BACK OUT THROUGH THE SHEATH. THE PHYSICIAN ELECTED TO USE A NON-BOSTON SCIENTIFIC STENT FOR FINAL TREATMENT, AS HE WAS CONCERNED THAT THERE WERE PIECES OF THE ELUVIA STILL WITHIN THE SFA. NO FURTHER DETAILS WERE PROVIDED DESPITE REQUEST BY BOSTON SCIENTIFIC.

  Patient problems: Foreign Body In Patient

  MAUDE report 21755260 ↗
• InjuryMar 20, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE STENT WAS NOT ADEQUATELY APPOSED TO THE VESSEL WALL, RESULTING IN OCCLUSION AND ADDITIONAL INTERVENTION. AN ELUVIA US, 6X150, 130 CM WAS SELECTED FOR USE. THE PATIENT WAS IMPLANTED WITH THE ELUVIA IN (B)(6) 2024. ON (B)(6) 2025, THE PATIENT PRESENTED WITH RECURRING SYMPTOMS. IT WAS REVEALED THAT THE ELUVIA WAS COMPLETELY OCCLUDED. IMAGING REVEALED THAT THE STENT WAS NOT APPOSED CORRECTLY TO THE VESSEL WALL. THE APPOSITION ISSUES WERE NOT EVIDENT ON ANGIOGRAPHY AT THE TIME THE STENT WAS PLACED. TO TREAT THE EVENT, AN ADDITIONAL STENT WAS PLACED TO COVER THE ABNORMAL PORTION OF THE ELUVIA.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21658127 ↗
• MalfunctionOct 22, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED DURING PREP. AN ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY TO TREAT A CASE OF PERIPHERAL ARTERY DISEASE. DURING PREPARATION FOR THE PROCEDURE, IT WAS NOTED THAT THE ELUVIA US, 6X150, 130 CM WAS PARTIALLY DEPLOYED OUTSIDE OF THE PATIENT. THE ELUVIA WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20505611 ↗
• InjuryOct 9, 2024Fracture; Difficult to Remove; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Difficult to Remove; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED THEN FRACTURED, RESULTING IN EMBOLIZATION, AND REQUIRING INTERVENTION. THIS 6X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE DURING A SUPERFICIAL FEMORAL ARTERY (SFA) STENTING PROCEDURE. THE 99% CHRONICALLY OCCLUDED SFA WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. DURING THE PROCEDURE, THE CHRONIC TOTAL OCCLUSION IN THE SFA/POPLITEAL WAS CROSSED AND THE LESION WAS PREDILATED USING A 4MM BALLOON, THEN THEY ADVANCED THE DEVICE TO BELOW KNEE POPLITEAL. AN ATTEMPT WAS MADE TO IMPLANT THIS STENT; HOWEVER, DURING DEPLOYMENT USING THE THUMB WHEEL, APPROXIMATELY 1CM OF THE STENT DEPLOYED. THE REMAINDER OF THE STENT DID NOT DEPLOY DESPITE FULLY ROLLING THE THUMB WHEEL BACK. THE BLUE HANDLE WAS THEN ATTEMPTED, BUT IT DISCONNECTED FROM THE DEVICE. THE STENT WAS ABLE TO BE BACKED OUT OVER THE WIRE, BUT WHEN TRYING TO PULL IT BACK IN THE SHEATH, THE EXPOSED PORTION OF STENT FRACTURED DISTALLY 10MM AND EMBOLIZED TO THE FEMORAL ARTERY. THE PIECE WAS ABLE TO BE SNARED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THE PROCEDURE WAS PROLONGED, BUT THE PATIENT FULLY RECOVERED. IT WAS FURTHER REPORTED THAT TH

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

  MAUDE report 20413081 ↗
• InjurySep 26, 2024Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED, AND STENT FRACTURE OCCURRED. THE PRE-DILATED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, 100% STENOSED DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A 6X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR THE PROCEDURE TO TREAT PERIPHERAL ARTERIAL DISEASE (PAD). AFTER A CONTRALATERAL APPROACH AND DEPLOYMENT OF FIRST 1/3-1/2 OF THE STENT, THE WHEEL WAS NO LONGER FUNCTIONAL, AND NEITHER WAS THE BLUE PULL. THE DEVICE WAS OPENED TO ATTEMPT TO MANUALLY DEPLOY, BUT THE STENT ELONGATED AND FRACTURED, PARTIALLY DEPLOYING IN THE SHEATH. A PORTION OF THE STENT WAS FORCEFULLY REMOVED, AND NON-BOSTON SCIENTIFIC STENTS WERE PLACED TO COVER THE SFA AND OVER STENT THE FRACTURED PORTION OF THE ELUVIA STENT. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20316817 ↗
• InjurySep 16, 2024Fracture; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION AS A RESULT OF STENT DAMAGE. AN ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A STENTING PROCEDURE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS REPORTED TO BE 50% STENOSED WITH MODERATE CALCIFICATION AND STANDARD TORTUOSITY. THE TARGET LESION WAS ACCESSED VIA A CONTRALATERAL APPROACH AND WAS PREDILATED. THE ELUVIA SYSTEM WAS ADVANCED OVER A V-18 CONTROLWIRE GUIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT WITHIN THE SFA, APPROXIMATELY HALF OF THE STENT WAS ABLE TO DEPLOY. THE STENT COULD NOT BE FULLY DEPLOYED USING NORMAL DEPLOYMENT MECHANISMS. THE HANDLE WAS TAKEN APART IN ORDER TO MANUALLY DEPLOY THE STENT. ONCE THE HANDLE WAS OPENED, IT WAS OBSERVED THAT THE DEPLOYMENT MECHANISMS WERE KINKED. APPROXIMATELY 80% OF THE DEPLOYED STENT WAS ELONGATED AND APPEARED FRACTURED. AS A RESULT OF THE DEVICE MALFUNCTION, THE PATIENT HAD TO UNDERGO A FULL BYPASS SURGERY OF THE FEMORAL ARTERY TO REMOVE THE STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232745 ↗
• InjurySep 10, 2024Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND STRETCHED, REQUIRING ADDITIONAL STENT PLACEMENT. A 6MM X 150MM, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A CONTRALATERAL APPROACH WAS USED TO ACCESS THE LESION. DURING THE PROCEDURE HALFWAY THROUGH DEPLOYMENT, THE STENT CEASED TO DEPLOY OVER THE NON-BOSTON SCIENTIFIC 0.014 GUIDEWIRE. THE THUMBWHEEL WORKED, BUT THE STENT DID NOT DEPLOY. THE PULL GRIP WAS ALSO USED IN AN ATTEMPT TO COMPLETE DEPLOYMENT. THE HANDLE WAS TAKEN APART, AND THE STENT WAS MANUALLY DEPLOYED. THE STENT ELONGATED SIGNIFICANTLY, APPROXIMATELY 10CM. THE DEPLOYMENT CATHETER BECAME STUCK TO THE GUIDEWIRE. GUIDEWIRE ACCESS WAS LOST IN ORDER TO REMOVE THE DEPLOYMENT CATHETER. THE ELONGATED STENT WAS RELINED WITH A NON-BOSTON SCIENTIFIC STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185592 ↗
• MalfunctionAug 26, 2024Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 6M X 150MM, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS OBSERVED THAT THE STENT WAS PARTIALLY DEPLOYED WHILE STILL IN THE PACKAGE. THE PRODUCT WAS NOT USED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064315 ↗
• MalfunctionAug 26, 2024Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 6M X 150MM, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS OBSERVED THAT THE STENT WAS PARTIALLY DEPLOYED WHILE STILL IN THE PACKAGE. THE PRODUCT WAS NOT USED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064308 ↗
• MalfunctionAug 26, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 6M X 150MM, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS OBSERVED THAT THE STENT WAS PARTIALLY DEPLOYED WHILE STILL IN THE PACKAGE. THE PRODUCT WAS NOT USED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064298 ↗
• MalfunctionAug 21, 2024Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED AND STRETCHED. A 6MM X 150MM, 130CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE TARGET LESION THAT WAS HIGHLY CALCIFIED AND LOCATED IN MODERATELY TORTUOUS ANATOMY. THE VESSEL WAS PREPPED WITH BALLOON ANGIOPLASTY. DURING THE PROCEDURE, AFTER DEPLOYING 2CM OF THE STENT, THE REST OF THE STENT WOULD NOT UN-SHEATH DESPITE USING THE THUMBWHEEL TO ITS MAXIMUM CAPABILITY. THE FORCE REQUIRED TO TURN THE THUMBWHEEL WAS HIGH. THE PULL GRIP WAS USED, BUT ADDITIONAL MANIPULATION TO THE DEPLOYMENT SYSTEM WAS REQUIRED IN ORDER TO DEPLOY THE STENT. THE DEPLOYMENT HANDLE WAS BROKEN OPEN IN ORDER TO DEPLOY THE STENT MANUALLY. THE STENT WAS ULTIMATELY IMPLANTED BUT ELONGATED 4CM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015515 ↗
• MalfunctionAug 13, 2024Positioning Failure; Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09AUG2024. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY AND BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN A LONG SEGMENT OF A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR A PERIPHERAL ARTERY STENTING PROCEDURE. THE LESION WAS CROSSED WITH A .014 NON-BOSTON SCIENTIFIC (BSC) GUIDWIRE, THEN BALLOON ANGIOPLASTY WAS USED TO PRE-DILATE THE VESSEL. THE ELUVIA STENT WAS INTRODUCED AND ADVANCED ACROSS THE LESION OVER THE .014 WIRE. IT WAS THEN ATTEMPTED TO DEPLOY THE STENT, BUT WHEN TURNING THE THUMB WHEEL, THE OUTER CATHETER FAILED TO RETRACT, THUS NO STENT DEPLOYMENT. WHEN IT WAS ATTEMPTED TO REMOVE THE ENTIRE DEVICE, IT WAS STUCK ON THE GUIDEWIRE. THE STENT CATHETER AND WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN INNOVA STENT. HOWEVER, DEVICE ANALYSIS REVEALED PARTIAL DEPLOYMENT OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977022 ↗