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	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	05/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: 53 years old at the time of study enrollment.
Event or Problem Description
It was reported that in stent occlusion of the right popliteal artery occurred requiring additional intervention.On (b)(6) 2023, the subject underwent treatment with this eluvia drug eluting stent as a part of a clinical trial.The target lesion #001 was in the right proximal popliteal artery extending up to the right mid popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 120 mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed by using 5.0 mm x 100 mm r2p crosstella rx percutaneous transluminal angioplasty (pta) balloon.A dissection of grade d was noted in the right proximal and mid popliteal artery post dilation of 5.0 mm x 100 mm r2p crosstella pta balloon, which was treated by placement of 6 mm x 120 mm eluvia drug eluting stent study device.Following post-dilation using 5.0 mm x 100 mm r2p crosstella pta balloon, the final residual stenosis was noted to be 15%.Post treatment, the dissection was resolved.On the same day, the subject was discharged from the hospital on aspirin and other anticoagulant medication.On (b)(6) 2023, in-stent thrombotic occlusion was noted in the right proximal and mid popliteal artery and was treated using thrombolysis.Post procedure 10% residual stenosis was noted.On (b)(6) 2023, the subject experienced symptoms of pain, redness, and swelling over the right foot along with history of popliteal stent occlusion and was hospitalized for further evaluation and treatment.On the same day, computed tomography angiography (cta) imaging revealed: right leg (target limb): mild atherosclerotic disease in the common iliac artery, external iliac artery and superficial femoral artery; moderate atherosclerotic disease in common femoral artery; patent profunda femoral artery; occluded popliteal artery with reconstitution of the distal popliteal artery prior to the trifurcation.On (b)(6) 2023, 208 days post index procedure, the occlusion noted in the right popliteal artery was treated by performing bypass surgery.Flow was established into the bypass graft with good palpable pulse noted in the proximal great saphenous vein.The below the knee popliteal artery was patent with mild plaque.Doppler examination demonstrated robust doppler signal in the bypass graft and distal popliteal artery.Palpable posterior tibial pulses were noted on completion of the procedure.On the same day, the event was considered to be resolved.On (b)(6) 2023, the subject was discharged from the hospital in stable condition and on aspirin.
Event or Problem Description
It was reported that in stent occlusion of the right popliteal artery occurred requiring additional intervention.On (b)(6) 2023, the subject underwent treatment with this eluvia drug eluting stent as a part of a clinical trial.The target lesion #001 was in the right proximal popliteal artery extending up to the right mid popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 120 mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed by using 5.0 mm x 100 mm r2p crosstella rx percutaneous transluminal angioplasty (pta) balloon.A dissection of grade d was noted in the right proximal and mid popliteal artery post dilation of 5.0 mm x 100 mm r2p crosstella pta balloon, which was treated by placement of 6 mm x 120 mm eluvia drug eluting stent study device.Following post-dilation using 5.0 mm x 100 mm r2p crosstella pta balloon, the final residual stenosis was noted to be 15%.Post treatment, the dissection was resolved.On the same day, the subject was discharged from the hospital on aspirin and other anticoagulant medication.On 28-may-2023, in-stent thrombotic occlusion was noted in the right proximal and mid popliteal artery and was treated using thrombolysis.Post procedure 10% residual stenosis was noted.On 14-dec-2023, the subject experienced symptoms of pain, redness, and swelling over the right foot along with history of popliteal stent occlusion and was hospitalized for further evaluation and treatment.On the same day, computed tomography angiography (cta) imaging revealed: right leg (target limb): mild atherosclerotic disease in the common iliac artery, external iliac artery and superficial femoral artery; moderate atherosclerotic disease in common femoral artery; patent profunda femoral artery; occluded popliteal artery with reconstitution of the distal popliteal artery prior to the trifurcation.On 16-dec-2023, 208 days post index procedure, the occlusion noted in the right popliteal artery was treated by performing bypass surgery.Flow was established into the bypass graft with good palpable pulse noted in the proximal great saphenous vein.The below the knee popliteal artery was patent with mild plaque.Doppler examination demonstrated robust doppler signal in the bypass graft and distal popliteal artery.Palpable posterior tibial pulses were noted on completion of the procedure.On the same day, the event was considered to be resolved.On 20-dec-2023, the subject was discharged from the hospital in stable condition and on aspirin.
Additional Manufacturer Narrative
A2 - age at time of event: 53 years old at the time of study enrollment.E1: initial reporter email: updated.

• 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: 23125281
• Report Number: 2124215-2025-66250
• Device Sequence Number: 21170233
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: (01)08714729876618(17)240208(10)28904689
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 02/08/2024
• Device Model Number: H74939294601210
• Device Catalogue Number: H74939294601210
• Device Lot Number: 0028904689
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 02/08/2022
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female
• Patient Race: White