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

Model Number	H74939294601510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in-stent restenosis occurred.On (b)(6) 2024, the patient underwent a selective right lower extremity aortogram, atherectomy, balloon angioplasty and stenting of the right superficial femoral artery.The right sfa was occluded with 100% stenosis from just distal to the origin to the distal thigh.Unable to cross antegrade.Therefore, right dpa access performed.Through and through wire access achieved.Rotablator 2.0 mm atherectomy performed to sfa, followed by 6 mm balloon angioplasty.Ivus showed flow-limiting dissection in the proximal/mid sfa.Therefore, a 6 x 150 mm eluvia drug-eluting stent placed with excellent result, no significant residual stenosis.3 mm balloon angioplasty to right dp access site for hemostasis.Excellent result at completion with brisk flow to foot.The procedure was successfully completed.There were no patient complications as a result of the event.On (b)(6) 2025, the patient underwent a procedure with a selective right lower extremity arteriogram, mechanical thrombectomy, balloon angioplasty and stenting of right superficial femoral artery; atherectomy and balloon angioplasty of right popliteal artery.The femoropopliteal pathology noted a thrombotic occlusion of an implanted eluvia stent in the right superficial femoral artery.Stenosis was estimated at 78% in the popliteal.Mechanical thrombectomy with a 6 french non-bsc device was performed.Balloon angioplasty performed to sfa and popliteal with a 6 mm ranger drug-coated balloon.Residual thrombus and sfa stent required second pass with non-bsc device.Residual stenosis present at distal aspect of stent as well as in the proximal sfa above the stent requiring placement of 2 eluvia 7 x 120 mm drug-eluting stents.These were post dilated with a 7 mm balloon and there was 20% stenosis postintervention.Popliteal lesion was 75% stenosis preintervention to less than 20% stenosis postintervention.Runoff was preserved with brisk flow to foot.The procedure was successfully completed.There were no patient complications as a result of the event.

• 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: 21951528
• Report Number: 2124215-2025-28153
• Device Sequence Number: 12934527
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: (01)08714729876625(17)260619(10)34405835
• 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): 05/02/2025

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: 06/19/2026
• Device Model Number: H74939294601510
• Device Catalogue Number: H74939294601510
• Device Lot Number: 0034405835
• 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: 04/07/2025
• Initial Report FDA Received Date: 05/02/2025
• Date Device Manufactured: 06/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male