ELUVIARecalls & reported problems across all models

We found 13 models of ELUVIA by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 310 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2019 and Sep 29, 2026 — classified as 3 deaths, 202 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (95 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ELUVIA problems

ELUVIA models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ELUVIA™ H74939294601210

  Stent, superficial femoral artery, drug-eluting
  1 death80 reports
• ELUVIA™ H74939294701210

  Stent, superficial femoral artery, drug-eluting
  58 reports
• ELUVIA™ H74939294601510

  Stent, superficial femoral artery, drug-eluting
  50 reports
• ELUVIA™ H74939294701510

  Stent, superficial femoral artery, drug-eluting
  31 reports
• ELUVIA™ H74939294601010

  Stent, superficial femoral artery, drug-eluting
  1 death20 reports
• ELUVIA™ H74939294600410

  Stent, superficial femoral artery, drug-eluting
  15 reports
• ELUVIA™ H74939294600810

  Stent, superficial femoral artery, drug-eluting
  1 death14 reports
• ELUVIA™ H74939294600610

  Stent, superficial femoral artery, drug-eluting
  12 reports
• ELUVIA™ H74939294700410

  Stent, superficial femoral artery, drug-eluting
  11 reports
• ELUVIA™ H74939294700610

  Stent, superficial femoral artery, drug-eluting
  9 reports
• ELUVIA™ H74939294700810

  Stent, superficial femoral artery, drug-eluting
  6 reports
• ELUVIA™ H74939294701010

  Stent, superficial femoral artery, drug-eluting
  3 reports
• ELUVIA™ H74939294701570

  Stent, superficial femoral artery, drug-eluting
  1 report

Recent ELUVIA adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED. ON (B)(6) 2021, AS PART OF THE CLINICAL TRIAL, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENTS. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 360 MM LESION LENGTH AND 100% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, LITHOTRIPSY WAS PERFORMED USING 5 MM X 60 MM SHOCKWAVE DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM, 3 MM X 220 MM COYOTE OTW PTA BALLOONS AND 3.5 MM X 120 MM SERRANATOR CUTTING BALLOON. THE TREATMENT OF STENOSIS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WAS PERFORMED BY DILATION USING 5 MM X 150 MM RANGER DRUG-COATED BALLOON, STUDY DEVICE. FOLLOWING WHICH 6 MM X 120 MM, 6 MM X 100 MM ELUVIA DRUG-ELUTING STENTS, STUDY DEVICE WAS PLACED IN T

  Patient problems: Obstruction/Occlusion

  MAUDE report 25818490 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED. ON (B)(6) 2021, AS PART OF THE CLINICAL TRIAL, THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON AND ELUVIA DRUG ELUTING STENTS. THE TARGET LESION #001 WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WITH 5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 4.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 360 MM LESION LENGTH AND 100% STENOSIS AND WAS CLASSIFIED AS TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, LITHOTRIPSY WAS PERFORMED USING 5 MM X 60 MM SHOCKWAVE DEVICE, PRE-DILATION WAS PERFORMED USING 4 MM X 220 MM, 3 MM X 220 MM COYOTE OTW PTA BALLOONS AND 3.5 MM X 120 MM SERRANATOR CUTTING BALLOON. THE TREATMENT OF STENOSIS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, MID SUPERFICIAL FEMORAL ARTERY, DISTAL SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY WAS PERFORMED BY DILATION USING 5 MM X 150 MM RANGER DRUG-COATED BALLOON, STUDY DEVICE. FOLLOWING WHICH 6 MM X 120 MM, 6 MM X 100 MM ELUVIA DRUG-ELUTING STENTS, STUDY DEVICE WAS PLACED IN T

  Patient problems: Obstruction/Occlusion

  MAUDE report 25818484 ↗
• MalfunctionApr 30, 2026Entrapment of Device; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND WAS ELONGATED. A 7X150, 130 CM ELUVIA WAS SELECTED FOR USE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, UPON DEPLOYMENT THE WHEEL BECAME PROBLEMATIC TO ROLL, CAUSING THE DEVICE TO BECOME STUCK ON THE WIRE. THE PHYSICIAN WAS ABLE TO PULL THE BLUE DEPLOYMENT ROD, AFTER WHICH THE ENTIRE STENT SUCCESSFULLY DEPLOYED. IT WAS ALSO NOTED THAT THE STENT WAS ELONGATED. THE PROCEDURE WAS COMPLETED WITH ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048849 ↗
• 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 ↗
• MalfunctionMar 30, 2026Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. A 7X150, 75 CM ELUVIA SELF-EXPANDING STENT WAS USED DURING AN ANGIOGRAM WITH INTERVENTION FOR ARTERIAL DISEASE. DEPLOYMENT ISSUES OCCURRED; PREMATURE DEPLOYMENT WAS NOTED AND THE STENT BECAME STUCK ON THE WIRE, PROLONGING THE PROCEDURE. IT WAS NOTED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735320 ↗
• 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 ↗
• InjuryFeb 17, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED THAT THE STENT WAS DAMAGED AND FAILED TO EXPAND, REQUIRING PLACEMENT OF ADDITIONAL STENT. THE 80-85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PERIPHERAL ARTERY. A 7X150, 130 CM ELUVIA STENT WAS SELECTED FOR TREATMENT. THE DEVICE WAS PREPARED AND ATTEMPTED TO BE DEPLOYED AS NORMAL VIA CONTRALATERAL APPROACH. HOWEVER, DURING DEPLOYMENT, IT WAS OBSERVED THAT THE DISTAL ONE-THIRD OF THE STENT APPEARED TWISTED, RESULTING IN ONLY 75-80% (120 MM) OF THE STENT EXPANDING FULLY. THE PROCEDURE WAS COMPLETED AFTER PLACEMENT OF A SECOND ELUVIA STENT TO OPEN THE TWISTED AREA, FOLLOWED BY LINING BOTH STENTS WITH A LONG NON-BOSTON SCIENTIFIC STENT GRAFT. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT FULLY RECOVERED FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367752 ↗
• 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 ↗
• InjuryJan 14, 2026Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT AND DAMAGE OCCURRED, RESULTING IN ADDITIONAL INTERVENTION. THE 80 % STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7X150, 130 CM ELUVIA WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON STENT DEPLOYMENT USING THE TURN WHEEL, THE TURN WHEEL FAILED TO RETRACT THE DEPLOYMENT SHEATH HALFWAY THROUGH. THE STENT WAS DEPLOYED 50 CM OUT OF 150CM. THE PHYSICIAN HAD TO PULL THE DELIVERY SYSTEM, WHICH ELONGATED THE STENT APPROXIMATELY 100CM, REQUIRING ADDITIONAL INTERVENTION. THE DEVICE WAS PULLED OUT OF THE BODY, AND AN ADDITIONAL ANGIOPLASTY WAS PERFORMED. IT WAS NOTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND PAIN; HOWEVER, THE PATIENT CONDITION WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Discomfort; Pain

  MAUDE report 24068462 ↗
• MalfunctionJan 8, 2026Premature Activation

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 7X40, 130 CM ELUVIA STENT WAS DELIVERED THROUGH A .035 AMPLATZ GUIDEWIRE VIA CONTRALATERAL APPROACH TO OVERLAP AND EXTEND LENGTH OF PREVIOUSLY DEPLOYED STENT. HOWEVER, PRIOR TO REACHING THE TARGET LESION AND REMOVING THE YELLOW SAFETY LOCK MECHANISM, THE STENT DEPLOYED PREMATURELY. AN ATTEMPT WAS MADE TO DEPLOY A NON-BOSTON SCIENTIFIC STENT, BUT UNSUCCESSFUL IN REACHING THE TARGET LOCATION. THE PHYSICIAN DECIDED AGAINST PURSUING ANY FURTHER INTERVENTION AND CHOSE NOT TO DEPLOY A STENT, ENDING THE CASE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PREVIOUSLY DEPLOYED 7X120 ELUVIA WAS NOT LONG ENOUGH TO COVER ENTIRETY THE LESION, WHICH IS WHY THE 7X40 WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003824 ↗
• 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 19, 2025Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIAL DEPLOYMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY VIA CONTRALATERAL FEMORAL APPROACH WITH THROUGH AND THROUGH ACCESS TO TIBIAL VESSEL. A 7X150,130CM ELUVIA STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT DEPLOYED ABOUT 100CM AND THEN FAILED. THE HANDLE BROKE APART TO REVEAL CATHETERS UNDERNEATH TO PIN AND PULL AND HAD TO STRAIGHTEN THE CATHETERS THAT HAD COILED UNDER THE THUMBWHEEL. CONSEQUENTLY, THE STENT BECAME STRETCHED OR ELONGATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851304 ↗
• 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 23839684 ↗

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