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

Model Number	H74939294700810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was occlusion of the target lesion three months post-treatment with eluvia where additional intervention was performed.The subject underwent treatment with eluvia drug-eluting stents on (b)(6) 2021 as a part of a clinical trial.The target lesion was in the left proximal superficial femoral artery, left mid superficial femoral artery and left distal superficial femoral artery.The lesion was described as 7 mm proximal reference vessel diameter and 7 mm distal reference vessel diameter with 260 mm lesion length; 100% stenosis and was classified as tasc ii d lesion.Prior to the target lesion treatment, pre-dilation was performed using 4 mm x 200 mm armada 18 pta balloon.Treatment of the target lesion was performed by the placement of 6 mm x 120 mm, 6 mm x 120 mm, 7 mm x 80 mm eluvia drug-eluting stents.Following, post-dilation was performed using 5 mm x 150 mm, and 6 mm x 80 mm sterling otw pta balloons.The final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital on clopidogrel and aspirin.On (b)(6) 2021, the subject was noted with symptoms related to occlusion of the left superficial femoral artery.On (b)(6) 2021, the subject was hospitalized for further evaluation and treatment.On the same day, bilateral lower limb angiography revealed left leg in-stent occlusion of superficial femoral artery and occlusion of p1 and p2 segments of popliteal artery.No significant stenosis of profunda femoris artery, anterior tibial artery, tibial peroneal trunk or peroneal artery, but did reveal occlusion of patent posterior tibial artery.On (b)(6) 2021, 82 days post- index procedure, occlusion noted in left proximal, mid and distal superficial femoral artery was treated by jetstream atherectomy followed by balloon angioplasty using 6 mm x 220 mm sterling balloon.Post procedure, the final residual stenosis was noted to be 0 percent.In addition, occlusion noted in the left proximal and mid popliteal artery was treated by 5 mm x 100 mm sterling balloon followed by 5.5 mm x 100 mm supera stent placement.Post treatment, the final residual stenosis was noted to be 0 percent.The subject was discharged on clopidogrel and apixaban.

• 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: 22136593
• Report Number: 2124215-2025-35953
• Device Sequence Number: 8526804
• Product Code: NIU
• UDI-Device Identifier: 08714729876717
• UDI-Public: (01)08714729876717(17)230420(10)27425093
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 04/20/2023
• Device Model Number: H74939294700810
• Device Catalogue Number: H74939294700810
• Device Lot Number: 0027425093
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 04/20/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Race: White