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

Model Number	H74939294601010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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 the left proximal and mid superficial femoral artery and f 4.5 mm x 100 mm supera stent was placed in left femoropopliteal junction.Following post-dilation by using 5 mm x 150 mm sterling drug coated balloon, the final residual stenosis was noted to be 20%.On the same day, per baseline core lab, during index procedure treatment of target lesion #001 post study device analysis drug coated balloon revealed complication of dissection of grade b.Per target lesion001, complication of dissection of grade e was noted due to 5 mm x 60 mm shockwave lithotripsy device.In response to the complication bailout stent was placed and on the same day the complication was considered to be resolved.In addition, post study device analysis of drug eluting stent revealed abrupt closure in left proximal superficial femoral artery, mid superficial femoral artery, distal superficial femoral artery and proximal popliteal artery.Post treatment of target lesion was performed by placement of 4.5 mm x 100 mm abbott vascular drug eluting stent and post-dilation by using 5 mm x 150 mm sterling drug coated balloon.On (b)(6) 2021, the subject was discharged from hospital.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25818490
• Report Number: 2124215-2026-37770
• Device Sequence Number: 20343089
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: (01)08714729876601(17)230310(10)27040255
• 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
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 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: 03/10/2023
• Device Model Number: H74939294601010
• Device Catalogue Number: H74939294601010
• Device Lot Number: 0027040255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 07/21/2026; 09/04/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 08/14/2026; 09/29/2026
• Date Device Manufactured: 03/10/2021
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White