MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	H74939294601210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thromboembolism (2654); Restenosis (4576)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred, requiring intervention.On (b)(6) 2024, an arteriogram with right leg revascularization was performed due to right lower extremity rest pain in the setting of ischemia.Findings included: left external iliac artery patent with severe stenosis noted; right common iliac stent patent with severe greater than 75% stenosis present; right external iliac artery and its stents also demonstrated severe greater than 75% stenosis resulting in hemodynamically significant inflow obstruction; right common femoral artery and its stent are patent with in-stent restenosis greater than 75%; right superficial femoral artery occluded throughout and popliteal are occluded down to the knee.Index procedure on the same day was performed, from both antegrade and retrograde approach, a 2.0 mm rotablator device was used to perform atherectomy of the common femoral artery, superficial femoral artery (sfa), and popliteal arteries to provide plaque modification diffusely diseased and calcified artery prior to angioplasty.Percutaneous transluminal angioplasty was performed of the femoral and popliteal arteries using 5 mm plain balloon.Follow-up angiogram showed significant residual stenosis and luminal irregularity which were flow-limiting; therefore, the sfa was stented using two eluvia drug-eluting self-expanding stents.Then pta was performed using 6 mm balloon.With restored outflow, pta of the right common iliac and external iliac severe in-stent stenosis was performed using overinflated 6 mm balloon.Completion angiogram was performed with good result.On (b)(6) 2025, the patient was diagnosed with right lower extremity critical limb threatening ischemia in the setting of rest pain with severe resting ischemia.It was found that the right common and external iliac arteries in their existing stents were patent, though there was greater than 70% in-stent stenosis in both the common external and external iliac arteries.The right internal iliac artery was patent with high-grade stenosis at its origin, and scattered atherosclerotic occlusive disease was noted.The right sfa was occluded at its origin with no distal reconstitution noted in the upper leg.The popliteal was occluded down to the knee joint at the distal aspect of the previously placed stent.Intervention was performed the same day in retrograde fashion.In order to provide plaque modification and vessel preparation of circumferentially calcified long segment occlusions of the sfa and popliteal arteries including recurrent occluded stents, this was first treated with atherectomy using rota rex device and then pta using a 6 mm plain balloon.Follow-up angiogram showed persistent flow-limiting stenosis in the sfa and popliteal arteries within the intervening segments between old stents.This was addressed by placement of eluvia self-expanding drug-eluting 7 mm x 120 stents.Pta of the stents was performed using a 6 mm balloon.Follow-up angiogram showed atheroembolic flow-limiting stenosis in both the tibioperoneal trunk and proximal peroneal arteries which were suspected to be the result of more proximal ballooning and stenting.These intraprocedural embolic events resulted in severe, greater than 70% flow-limiting stenosis in the tibioperoneal trunk/peroneal arteries and were addressed with secondary percutaneous thrombectomy using a catheter directed aspiration technique.Pta was then performed using 3 mm plain balloon, follow-up angiogram was performed with acceptable results.Pta was then performed of the right common iliac artery using a 7 mm plain balloon, and of the right external iliac lesions using 7 mm plain balloon.The procedure was completed and there were no patient complications.

• Brand Name: ELUVIA
• 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: 21439979
• Report Number: 2124215-2025-06134
• Device Sequence Number: 4683404
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• 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): 02/21/2025

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: 09/07/2024
• Device Model Number: H74939294601210
• Device Catalogue Number: H74939294601210
• Device Lot Number: 0030361659
• 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: 01/28/2025
• Initial Report FDA Received Date: 02/21/2025
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELUVIA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown