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); Arteriosclerosis/ Atherosclerosis (4437); Unspecified Vascular Problem (4441)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via study that the subject experienced peripheral artery disease and in-stent occlusion resulting in additional intervention.The subject underwent treatment with the eluvia drug-eluting stent on (b)(6) 2025 as a part of the clinical trial.The target lesion was in the left distal superficial femoral artery (sfa) with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length of 100 mm and 100% stenosis and was classified as tasc ii c lesion.An occlusion was also noted in the left sfa and proximal popliteal artery.Prior to the target lesion treatment with the study device, pre-dilation was performed using 4 mm x 60 mm coyote pta balloon.Treatment of the target lesion was performed by the placement of 6 mm x 120 mm eluvia drug eluting stent study device.Following stent placement, post-dilation was performed using 4 mm x 60 mm coyote pta balloon.The final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2025, the subject visited hospital for 30 days follow up and reported that the symptoms remained unchanged and denied any improvements after the index procedure.Physical examination in lower extremities revealed 2+ femoral pulses bilaterally and bilateral popliteal, and pedal pulses were non-palpable.Based on lower extremity arterial duplex findings, the subject was scheduled for left lower extremity and revascularization of occluded stent on later date.On (b)(6) 2025, the subject visited the hospital for scheduled angiogram with complaints of worsening of claudication and was hospitalized for further evaluation and treatment.On physical examination, pulses in left lower extremity were palpable pt, monophasic dorsalis pedis artery.On right lower extremity monophasic anterior tibial artery.Left lower extremity angiogram performed revealed in-stent occluded of left sfa.Occlusion noted in the left sfa stent was treated by 4 mm x 200 mm balloon angioplasty and subsequently, thrombolysis was initiated.On (b)(6) -2025, left leg angiogram was performed and thrombolysis was discontinued.Subsequently 7 mm x 40 mm non-boston scientific drug eluting stent was placed in proximal sfa and was post dilated.Post procedure angiogram revealed patent common femoral artery, profunda, improved flow in sfa, patent popliteal artery without flow limiting stenosis.Runoff was via posterior tibial artery.The event was considered to be resolved.On (b)(6) 2025, the subject was discharged from the hospital on dual antiplatelet therapy.
Additional Manufacturer Narrative
A2 - age at time of enrollment: the subject was 72 years old at the time of study enrollment.
Event or Problem Description
It was reported via study that the subject experienced peripheral artery disease and in-stent occlusion resulting in additional intervention.The subject underwent treatment with the eluvia drug-eluting stent on (b)(6) 2025 as a part of the clinical trial.The target lesion was in the left distal superficial femoral artery (sfa) with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length of 100 mm and 100% stenosis and was classified as tasc ii c lesion.An occlusion was also noted in the left sfa and proximal popliteal artery.Prior to the target lesion treatment with the study device, pre-dilation was performed using 4 mm x 60 mm coyote pta balloon.Treatment of the target lesion was performed by the placement of 6 mm x 120 mm eluvia drug eluting stent study device.Following stent placement, post-dilation was performed using 4 mm x 60 mm coyote pta balloon.The final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2025, the subject visited hospital for 30 days follow up and reported that the symptoms remained unchanged and denied any improvements after the index procedure.Physical examination in lower extremities revealed 2+ femoral pulses bilaterally and bilateral popliteal, and pedal pulses were non-palpable.Based on lower extremity arterial duplex findings, the subject was scheduled for left lower extremity and revascularization of occluded stent on later date.On (b)(6) 2025, the subject visited the hospital for scheduled angiogram with complaints of worsening of claudication and was hospitalized for further evaluation and treatment.On physical examination, pulses in left lower extremity were palpable pt, monophasic dorsalis pedis artery.On right lower extremity monophasic anterior tibial artery.Left lower extremity angiogram performed revealed in-stent occluded of left sfa.Occlusion noted in the left sfa stent was treated by 4 mm x 200 mm balloon angioplasty and subsequently, thrombolysis was initiated.On (b)(6) 2025, left leg angiogram was performed and thrombolysis was discontinued.Subsequently 7 mm x 40 mm non-boston scientific drug eluting stent was placed in proximal sfa and was post dilated.Post procedure angiogram revealed patent common femoral artery, profunda, improved flow in sfa, patent popliteal artery without flow limiting stenosis.Runoff was via posterior tibial artery.The event was considered to be resolved.On (b)(6) 2025, the subject was discharged from the hospital on dual antiplatelet therapy.It was further reported that the target lesion was in the left mid sfa and left proximal popliteal artery in addition to the previously reported left distal sfa.Post-stent dilation during the index procedure was performed using a 45 mm x 100 mm sterling pta balloon.The occlusion noted in the left lower extremity angiogram on (b)(6) 2025 extended into the proximal popliteal.
Additional Manufacturer Narrative
A2 - age at time of enrollment: the subject was 72-year-old at the time of study enrollment.Updated fields: b5 - describe event or problem.

• 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: 22516119
• Report Number: 2124215-2025-45408
• Device Sequence Number: 8078771
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: (01)08714729876618(17)260712(10)34590653
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 07/12/2026
• Device Model Number: H74939294601210
• Device Catalogue Number: H74939294601210
• Device Lot Number: 0034590653
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 07/12/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: Black Or African American