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 Codes	Ischemia (1942); Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in-stent restenosis and ischemia occurred, requiring intervention.On (b)(6) 2023, this 6x40, 130 cm eluvia drug-eluting vascular stent system was selected for use in an atherectomy and balloon angioplasty of the right superficial femoral artery (sfa) and popliteal artery, and stenting of the right sfa.Atherectomy was performed to debulk the in-stent restenosis of an unknown stent.Repeat imaging showed persistent residual stenosis; therefore, this stent was deployed at the proximal end of the existing stent, overlapping approximately 5 mm.Balloon angioplasty was then performed to the distal sfa and above-knee popliteal with a 5 x 200 mm balloon inflated for 3 minutes.Final imaging showed an excellent result with no significant residual stenosis, brisk flow and preserved runoff.On (b)(6) 2024, selective right lower extremity arteriogram, atherectomy, balloon angioplasty of the right sfa, percutaneous mechanical thrombectomy of the right popliteal artery, and intravascular ultrasound were performed due to peripheral artery disease with acute limb threatening ischemia.Imaging showed the proximal sfa was patent; however, the two overlapping stents were occluded from the distal sfa to the above knee popliteal artery.There appeared to be chronic atherosclerotic stenosis in the sfa just proximal to the stent.The sfa was occluded at the origin of the stent.Atherectomy was performed of the sfa lesion and mechanical thrombectomy of the thrombosed popliteal stent from the distal sfa to the above knee popliteal.Repeat imaging showed a patent flow lumen with some irregularity; therefore, angioplasty was performed with a drug coated balloon.Repeat imaging showed a good result in the sfa and popliteal.No 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 IRELAND LIMITED
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18731994
• Report Number: 2124215-2024-07991
• Device Sequence Number: 5943967
• Product Code: NIU
• UDI-Device Identifier: 08714729876571
• UDI-Public: 08714729876571
• 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: 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): 02/19/2024

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 Model Number: 24657
• Device Catalogue Number: 24657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JETSTREAM; JETSTREAM, RANGER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female