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	01/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in-stent restenosis occurred.On (b)(6) 2023, the patient had more than 80% stenosis in the proximal popliteal artery.Successful recanalization of the right femoropopliteal segment using jetstream atherectomy, 5 mm balloon angioplasty, and 6 mm x 80 mm drug-eluting stent placement.The 6mm x 80mm x 130cm eluvia drug-eluting vascular stent was placed in the proximal popliteal artery.Post-intervention angiography showed right femoropopliteal segment widely patent with two-vessel anterior tibial and peroneal runoff to right foot.On (b)(6) 2024, recanalization of right femoropopliteal segment with atherectomy, balloon angioplasty, and the drug-eluting stent placement was performed.There was more than 70% stenosis in mid superficial femoral artery (sfa).Focal, pre-occlusive stenosis in distal right sfa at the proximal end of the right sfa stent.Diffuse, more than 80% stenosis of the mid and distal right popliteal artery with the peroneal runoff to foot.Mechanical atherectomy of the steno-occlusive disease in right femoropopliteal segment performed in a proximal to distal fashion for a total of 5.31 minutes, then, post angioplasty performed using 5mm x 80mm balloon.Then, stenting of the significant residual stenosis in the distal right sfa performed using 6 mm x 80 mm eluvia stent with the 1cm overlap with the previously placed distal stent.Past angioplasty performed using 5 mm balloon.Angioplasty of the right popliteal artery performed using 4 mm x 100 mm balloon.Post angioplasty right femoropopliteal arteriogram showed widely patent right femoropopliteal segment.

• 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: 18584491
• Report Number: 2124215-2024-03804
• Device Sequence Number: 20894680
• Product Code: NIU
• UDI-Device Identifier: 08714729876595
• UDI-Public: 08714729876595
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2024

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: 09/29/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028307257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: 75 YR
• Patient Sex: Female