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	08/15/2024
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 intravascular ultrasound evaluation of left iliac, common femoral, superficial femoral, popliteal, and anterior tibial arteries for diagnostic and intervention planning purposes.Left superficial femoral artery was heavily diseased with scattered areas of stenosis throughout the proximal thigh and chronic total occlusion in the mid-thigh.Popliteal reconstitutes at the patella.Single-vessel runoff through the anterior tibial artery which is diseased with most notable stenosis greater than 75% in the proximal calf but patent down to the foot.Atherectomy was performed in the chronically occluded left superficial femoral and popliteal using a 1.5mm rotablator device.Balloon angioplasty was performed using a 6mm balloon.There was a notable flow-limiting dissection within the superficial femoral which was stented using 7x120mm, 7x120mm, and 6x100mm eluvia drug-coated self-expanding stents.Good result from revascularization with restored vessel in line flow to the foot through the anterior tibial artery.There was residual dissection proximal and distal to the superficial femoral stents but did not appear to be flow limiting.On (b)(6) 2024, a left lower extremity arteriogram was obtained, which showed the superficial femoral artery occluded just distal to its origin.The stents were occluded.There was reconstitution of the above-knee popliteal.A lysis catheter was placed.A 4f non-boston scientific infusion catheter with a 50cm infusion length was advanced and positioned such that the infusion length spanned from the left common femoral artery to the mid popliteal artery.The infusion catheter was packed with 2mg of tpa.The patient tolerated the procedure well and was taken to the icu in stable condition.

• 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: 20224624
• Report Number: 2124215-2024-57101
• Device Sequence Number: 17970840
• 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: 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): 09/16/2024

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: 02/25/2026
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0033774401
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/16/2024
• Date Device Manufactured: 02/26/2024
• 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: 63 YR
• Patient Sex: Male