MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA?; Stent, Superficial Femoral Artery, Drug-Eluting

Model Number	H74939294600610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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 performed by using 6 mm x 60 mm sterling otw pta balloon.The final residual stenosis was noted to be 5%.On (b)(6) 2025, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2026, the subject was noted with symptoms related to peripheral vascular disease.On (b)(6) 2026, 533 days post index procedure, occlusion noted in left proximal superficial femoral artery and left mid superficial femoral artery was revascularized by performing balloon angioplasty using 6 mm x 200 mm and 6 mm x 60 mm ranger drug coated balloons and placement of 6 mm x 100 mm and 6 mm x 60 mm eluvia drug eluting stents.The final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved.
Additional Manufacturer Narrative
A2 - age at time of event: 48 years old at the time of study enrollment investigation results: device history record (dhr) review: the device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the eluvia device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50933065
• Report Number: 2124215-2026-51666
• Device Sequence Number: 18831227
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: (01)08714729876588(17)260208(10)33567510
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 02/08/2026
• Device Model Number: H74939294600610
• Device Catalogue Number: H74939294600610
• Device Lot Number: 0033567510
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 02/09/2024
• 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: Required Intervention
• Patient Sex: Male
• Patient Race: Black Or African American