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	Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred, requiring 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 left proximal superficial femoral artery (sfa), left mid sfa, and left distal sfa, with 5.2 mm proximal reference vessel diameter and 5.2 mm distal reference vessel diameter with 20 mm lesion length with 100% stenosis.Treatment of the target lesion was performed by placement of 7 mm x 150 mm eluvia drug eluting stent and dilation using 6 mm x 150 mm ranger drug coated balloon, study devices.Following treatment was performed by placement of 6 mm x 150 mm eluvia drug eluting stent and 6 mm x 60 mm non-boston scientific drug eluting stent.Post procedure, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2025 occlusion noted in the left common femoral artery and stenosis noted in the left proximal sfa and were accessed by longitudinal arteriotomy from the left common femoral artery to proximal sfa.Followed by endarterectomy was performed and arteriotomy was closed with bovine pericardial patch.On (b)(6) 2025 the subject was discharged from the hospital on plavix.
Additional Manufacturer Narrative
A2: patient age: 76 years old (at the time of enrollment).
Event or Problem Description
It was reported that restenosis occurred, requiring 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 left proximal superficial femoral artery (sfa), left mid sfa, and left distal sfa, with 5.2 mm proximal reference vessel diameter and 5.2 mm distal reference vessel diameter with 20 mm lesion length with 100% stenosis.Treatment of the target lesion was performed by placement of 7 mm x 150 mm eluvia drug eluting stent and dilation using 6 mm x 150 mm ranger drug coated balloon, study devices.Following treatment was performed by placement of 6 mm x 150 mm eluvia drug eluting stent and 6 mm x 60 mm non-boston scientific drug eluting stent.Post procedure, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2025 occlusion noted in the left common femoral artery and stenosis noted in the left proximal sfa and were accessed by longitudinal arteriotomy from the left common femoral artery to proximal sfa.Followed by endarterectomy was performed and arteriotomy was closed with bovine pericardial patch.On (b)(6) 2025 the subject was discharged from the hospital on plavix.It was further reported that the adverse events were not related to the study devices.It was confirmed that the left sfa was treated with eluvia 7 mm x 150 mm.
Additional Manufacturer Narrative
A2: patient age: 76 years old (at the time of enrollment).
Event or Problem Description
It was reported that restenosis occurred, requiring 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 left proximal superficial femoral artery (sfa), left mid sfa, and left distal sfa, with 5.2 mm proximal reference vessel diameter and 5.2 mm distal reference vessel diameter with 20 mm lesion length with 100% stenosis.Treatment of the target lesion was performed by placement of 7 mm x 150 mm eluvia drug eluting stent and dilation using 6 mm x 150 mm ranger drug coated balloon, study devices.Following treatment was performed by placement of 6 mm x 150 mm eluvia drug eluting stent and 6 mm x 60 mm non-boston scientific drug eluting stent.Post procedure, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2025 occlusion noted in the left common femoral artery and stenosis noted in the left proximal sfa and were accessed by longitudinal arteriotomy from the left common femoral artery to proximal sfa.Followed by endarterectomy was performed and arteriotomy was closed with bovine pericardial patch.On (b)(6) 2025 the subject was discharged from the hospital on plavix.It was further reported that the adverse events were not related to the study devices.It was confirmed that the left sfa was treated with eluvia 7 mm x 150 mm.
Additional Manufacturer Narrative
A2: patient age: 76 years old (at the time of enrollment).Corrections to: h6 patient codes, impact codes.

• 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: 22149709
• Report Number: 2124215-2025-36937
• Device Sequence Number: 8478076
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: (01)08714729876625(17)241006(10)30459919
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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 Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2025

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: 10/06/2024
• Device Model Number: H74939294601510
• Device Catalogue Number: H74939294601510
• Device Lot Number: 0030459919
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 11/05/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/23/2025; 11/06/2025
• Date Device Manufactured: 10/07/2022
• 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: Required Intervention
• Patient Sex: Male
• Patient Race: White