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

Model Number	24657
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in-stent restenosis occurred.On (b)(6) 2024, the patient presented with atherosclerosis of native arteries of extremities with intermittent claudication and rest pain in the left leg.The patient had severe lower leg pain and loss of sensation in the left foot for the past 2 weeks and was unable to sleep due to left foot pain.The patient underwent left to lower extremity arteriogram, which revealed long segment occlusion of the left superficial femoral artery (sfa) and proximal popliteal artery with the two-vessel runoff to foot.There was successful recanalization of the left femoropopliteal segment using 3.4mm jetstream atherectomy for a total of 18.52 minutes, followed by 5mm x 150mm balloon angioplasty, and then placement of a 6mm x 120mm eluvia drug-eluting stent in the distal sfa/proximal popliteal artery.Post dilation performed using a 5mm x 150mm balloon.No residual stenosis.Patient tolerated the procedure well.No immediate procedural complications.On (b)(6) 2024, the patient presented with atherosclerosis of native arteries of extremities with rest pain in the left leg.There was worsening of left foot pain for the past 2 weeks with duplex evidence of left femoropopliteal occlusion.The patient underwent a left lower extremity arteriogram, which revealed long segment occlusion in the left sfa and proximal popliteal artery with a diffuse preocclusive disease in mid popliteal artery and more than 70% stenosis in proximal anterior tibial artery and the tibioperoneal trunk and proximal peroneal occlusion.Access was obtained, and mechanical atherectomy of the left femoropopliteal segment was performed in a proximal to distal fashion using 2.4-3.4 mm jetstream device for a total of 15.07 minutes.Post atherectomy, balloon dilation performed using 3.5mm x 150mm balloon in a distal to proximal fashion.Then, stenting of the more than 40% residual stenosis in proximal left sfa performed using a 6 mm x 120 mm eluvia drug-eluting stent.Post dilation performed using 5 mm x 150 mm balloon.Then, left upper leg arteriogram obtained which showed widely patent left femoropopliteal segment.Two-vessel anterior tibial and peroneal runoff to left ankle.Patient tolerated the procedure well.No immediate procedural complications.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• 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: 19922022
• Report Number: 2124215-2024-48621
• Device Sequence Number: 12806422
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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: 10/25/2025
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0032853487
• 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: 07/11/2024
• Initial Report FDA Received Date: 08/06/2024
• Date Device Manufactured: 10/26/2023
• 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: 68 YR
• Patient Sex: Female