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	Obstruction/Occlusion (2422)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in-stent occlusion occurred.On (b)(6) 2024, the patient underwent an arteriogram with right leg revascularization.Wire and catheter taken down the superficial femoral and popliteal arteries with selective angiography at each level.Superficial femoral-popliteal occlusion crossed, and catheter taken down the level of patent distal popliteal lumen.Atherectomy was performed in the superficial femoral and popliteal occlusions with a 2.0 mm rotablator.Then angioplasty was performed using a 5mm plain balloon.Follow-up angiogram showed segment of significant luminal irregularity in severe residual stenosis therefore this portion in the distal superficial femoral artery (sfa) was stented using a 6 x 60 mm eluvia drug-eluting open cell self-expanding stent.This was post-dilated using a 5 mm balloon which was overexpanded.Completion angiogram performed.Catheter and sheath and wire removed.Good result.Palpable pedal pulses present post intervention.On (b)(6) 2024, the patient underwent an arteriogram with right leg revascularization.Wire and catheter taken down the right superficial femoral and popliteal arteries with selective angiography performed at each level.Wire and catheter taken down to patent popliteal artery below the knee.Angiogram performed.Intravascular ultrasound taken out over wire and used to evaluate the right iliac, common femoral, superficial femoral, and popliteal arteries with the following findings: right sfa patent proximally with occlusion in the mid-thigh, distal sfa stent occluded with reconstitution of popliteal at the level of the patella.Based on angiographic and intravascular ultrasound findings, artery and stent acutely thrombosed which may be due to underlying atherosclerotic disease proximal and distal to the existing stent.A 6fr non-boston scientific atherectomy device was used in the right superficial femoral and popliteal arteries.Balloon angioplasty was performed using a 5mm plain balloon.Repeat angiogram showed superficial femoral and popliteal to be patent with flow limiting filling defect above the previously placed superficial femoral stent.This was addressed with proximal extension of the superficial femoral stenting with placement of a 6 x 80 mm self-expanding drug-eluting stent.This was post dilated using a 6mm balloon.Completion angiogram performed with satisfactory result.Catheter and sheath and wire removed.There was restored dorsalis pedis pulse in the foot post intervention.Good result from revascularization with restored three-vessel in line flow to the right foot.No residual flow limiting lesions on completion angiogram.

• 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: 19625326
• Report Number: 2124215-2024-38937
• Device Sequence Number: 8121845
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: 08714729876588
• 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: 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): 06/27/2024

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: 09/10/2025
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0032578476
• 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: 06/03/2024
• Initial Report FDA Received Date: 06/27/2024
• Date Device Manufactured: 09/11/2023
• 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: 69 YR
• Patient Sex: Unknown