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	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Restenosis guarantee program.It was reported that restenosis occurred, requiring intervention.On (b)(6) 2024, this 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in an abdominal aortogram and left lower extremity arteriogram for recanalization of a left superficial femoral artery (sfa) occlusion.During the procedure, mechanical atherectomy of the left sfa was performed in a proximal to distal fashion.Post angioplasty was performed using a 5mm x150mm balloon catheter.There was significant residual stenosis and dissection in the mid-left sfa; therefore, the mid and distal sfa was treated with this 6x120, 130 cm eluvia drug-eluting vascular stent.The patient tolerated the procedure well and there were no immediate procedural complications.On (b)(6) 2024, greater than 60% residual stenosis of the mid-left sfa was noted.This segment was treated with a 6mmx140mm non-boston scientific stent.Post dilation was performed using a 6mm balloon.The patient tolerated the procedure well and there were no 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: 20582051
• Report Number: 2124215-2024-64754
• Device Sequence Number: 8106373
• 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): 10/31/2024

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: 10/08/2025
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0032758091
• 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: 10/09/2024
• Initial Report FDA Received Date: 10/31/2024
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male