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 Codes	Pain (1994); Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Restenosis guarantee program it was reported that in-stent restenosis occurred, requiring intervention.On (b)(6) 2024, this 7x120, 130 cm eluvia was selected for use in an arteriogram with left leg revascularization procedure.During the procedure, multiple wire and catheter combinations were used to cannulate the occluded superficial femoral artery origin.An up and over through and through wire access approach was obtained from the left pedal to the right femoral access sheaths.Due to long chronic occlusion with dense calcification, a 2.5 mm rotablator device was used to perform femoral-popliteal atherectomy.Balloon angioplasty was performed of the common femoral, superficial femoral, and popliteal arteries using 6 mm plain balloon.Follow-up angiogram showed restored flow through the femoral and popliteal arteries but with severe residual stenosis and multiple areas of flow-limiting dissection.Repeat balloon angioplasty was performed with prolonged inflation but with persistent results.This was addressed with stenting with five eluvia stents which ultimately required extension from the superficial femoral origin down to the popliteal at the knee stents.Balloon angioplasty was performed again using 6 mm balloon.Follow-up arteriogram showed excellent flow through the recanalized femoral and popliteal arteries.The procedure was completed and there were no patient complications.On (b)(6) 2024, the subject presented with left lower extremity ischemic rest pain; therefore, left lower extremity arteriogram was performed.The left superficial femoral artery was occluded just past its origin with thrombus present throughout the superficial femoral and popliteal stents throughout the thigh and above the knee.There was extension of the thrombus distal to the popliteal stent as well.There was acute on chronic thrombus present in the superficial femoral- popliteal arteries as well as circumferential atherosclerotic hyperplasia throughout, suggestive of progressive chronic atherosclerotic occlusive disease; both components contributing to re-occlusion of the femoral-popliteal stents.After extensive thrombectomy and atherectomy followed by repeated balloon angioplasty, two-vessel inline flow was restored to the left foot.There was noted to be excellent perfusion at the completion of the procedure.The subject was started on dual antiplatelet therapy with plavix and aspirin.

• 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: 21277611
• Report Number: 2124215-2025-01052
• Device Sequence Number: 9320554
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: 03/21/2026
• Device Model Number: H74939294701210
• Device Catalogue Number: H74939294701210
• Device Lot Number: 0033889949
• 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: 01/06/2025
• Initial Report FDA Received Date: 01/30/2025
• Date Device Manufactured: 03/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7X120MM(2), 7X80MM, 7X60 MM ELUVIA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male