MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA?; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	H74939294601210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Perforation of Vessels (2135)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: 62 years old (at the time of enrollment).
Event or Problem Description
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 device analysis of the drug-eluting stent revealed a complication of perforation and arteriovenous fistula in the right distal superficial femoral artery.

• Brand Name: ELUVIA?
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23839684
• Report Number: 2124215-2025-91721
• Device Sequence Number: 9959340
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: (01)08714729876618(17)230611(10)27695063
• Combination Product (Y/N): Y
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: H74939294601210
• Device Catalogue Number: H74939294601210
• Device Lot Number: 0027695063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• Date Device Manufactured: 06/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White