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

Model Number	H74939294601210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three months post-implant there was significant thrombus that required an additional stent.A procedure was performed on (b)(6) 2025 due to atherosclerosis of native arteries of extremities with intermittent claudication.Circumferential calcification of the right superficial femoral artery.Significant dissection in the mid/distal sfa following atherectomy and balloon angioplasty requiring placement of two 6 x 120 mm eluvia drug-eluting overlapping stents with excellent result.On (b)(6) 2025, an ivus procedure was performed due to right leg resting pain and found thrombotic occlusion of right sfa.The results went from 100 percent stenosis preintervention to less than 20 percent stenosis post-intervention, but with significant residual "flap" in mid-stent treated with 6 x 150 mm eluvia drug-eluting stent within the existing stent.Additional unrelated lesions were treated as well.A 6 french celt percutaneous closure device deployed in left common femoral access site upon completion resulting in excellent hemostasis.

• 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: 22173326
• Report Number: 2124215-2025-37915
• Device Sequence Number: 9218545
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: (01)08714729876618(17)260712(10)34590653
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 07/12/2026
• Device Model Number: H74939294601210
• Device Catalogue Number: H74939294601210
• Device Lot Number: 0034590653
• 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: 05/15/2025
• Initial Report FDA Received Date: 06/10/2025
• Date Device Manufactured: 07/12/2024
• 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
• Patient Age: 64 YR
• Patient Sex: Unknown