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	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Eluvia restenosis program: it was reported that the patient underwent a revascularization procedure 272 days following the index procedure.On (b)(6) 2022, the patient underwent an atherectomy procedure to treat atherosclerotic peripheral vascular disease with claudication.The target lesion was located within the left superficial femoral artery (sfa) and p1 popliteal artery.Retrograde access was obtained to the right common femoral artery.Using imaging guidance, a catheter and guidewire were positioned across the area of stenosis.A non-bsc filter wire was positioned in the p3 popliteal artery.Mechanical atherectomy in the left sfa and popliteal artery was then performed using a jetstream catheter.Percutaneous transluminal balloon angioplasty was then performed using an unknown balloon along the length of the sfa and p1 popliteal artery.Follow-up imaging demonstrated suboptimal results.Balloon angioplasty was repeated, but no significant change was noted.Transcatheter stenting was then performed at the p1 popliteal artery with an eluvia drug-eluting vascular stent.The stent was post dilated using an unknown 6x100 mm balloon.Follow-up imaging demonstrated excellent results.The non-bsc filter wire was retrieved, and completion arteriogram shows no evidence of distal embolization.The patient tolerated the procedure well.On (b)(6) 2023, 272 days post index procedure, the patient underwent a revascularization procedure.The target lesion was located within the left sfa and popliteal artery.Retrograde access was obtained to the right common femoral artery.Using image guidance, a catheter and guidewire were positioned across the area of stenosis.A non-bsc filter wire was positioned in the p3 popliteal artery.Mechanical atherectomy in the left sfa and popliteal artery was then performed using a jetstream catheter.Percutaneous transluminal balloon angioplasty was then performed using an unknown balloon along the length of the sfa and popliteal artery.Follow-up imaging demonstrated suboptimal results due to moderate residual stenosis.Balloon angioplasty was repeated using a ranger drug-coated balloon, but moderate residual stenosis remained the same in the mid sfa.Transcatheter stenting was then performed using an eluvia drug-eluting vascular stent.Balloon angioplasty was then performed using an unknown angioplasty balloon.Follow-up imaging demonstrated excellent results.The patient tolerated the procedure well.No further patient complications were reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17087742
• Report Number: 2124215-2023-29404
• Device Sequence Number: 17685428
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• 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: 2022
• 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): 06/08/2023

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: 08/19/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028043225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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: 86 YR
• Patient Sex: Unknown