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

Model Number	H74939294701210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical trial.It was reported that the subject suffered restenosis of the target lesion, requiring hospitalization and additional intervention.The subject underwent treatment with the eluvia drug eluting stent on (b)(6) 2024 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery with 7 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length 100 mm with 80% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed using 6 mm x 100 mm sterling pta balloon.Treatment of target lesion was performed by dilation of 7 mm x 120 mm eluvia drug eluting stent study device.Following, post-dilation was performed using 6 mm x 100 mm sterling pta balloon and a non-boston scientific balloon.Post procedure, the final residual stenosis was noted to be 0%.On (b)(6) 2024, the subject was discharged from the hospital.On (b)(6) 2024, subject visited the hospital for 6-month follow-up assessment, and the abi and pvr tracings at rest, showed evidence of mild to moderate peripheral arterial insufficiency and lack of calf waveform augmentation which suggested high grade stenosis and occlusion at the left superficial femoral artery (sfa).On (b)(6) 2024, 308 days post-index procedure, the subject was admitted to hospital with persistent symptoms of left lower extremity claudication and to undergo peripheral angiogram and possible intervention.On the same day, in-stent occlusion noted in left proximal superficial femoral artery was treated by dilation using 6 mm x 100 mm and 7 mm x 100 mm sterling pta balloons, followed by drug coated balloon angioplasty using 7 mm x 150 mm ranger dcb.Chronic total occlusion noted in left distal sfa and left proximal popliteal artery was treated by intravascular lithotripsy using a non-boston scientific catheter followed by angioplasty using 3 mm x 60 mm coyote balloon and a non-boston scientific scoring balloon and drug coated balloon angioplasty using 6 mm x 100 mm ranger dcb.Post treatment, the final residual stenosis was noted to be 0%.On the same day, the event was considered resolved.On (b)(6) 2024, subject was discharged from hospital in stable condition on dual antiplatelet therapy.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 48 years old at the time of study enrollment.

• 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: 20924299
• Report Number: 2124215-2024-77770
• Device Sequence Number: 5068505
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/13/2024

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: 07/07/2024
• Device Model Number: H74939294701210
• Device Catalogue Number: H74939294701210
• Device Lot Number: 0029960184
• 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: 11/21/2024
• Initial Report FDA Received Date: 12/13/2024
• Date Device Manufactured: 07/08/2022
• 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 Sex: Male
• Patient Ethnicity: Hispanic