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	Numbness (2415); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Date of Event	10/18/2024
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 mid superficial femoral artery (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) 2024, the subject visited the hospital for follow up and underwent bilateral lower extremity arterial doppler ultrasound which revealed: left lower extremity (target limb) new probable in-stent restenosis throughout the sfa stent, with multifocal stenoses leading to a patent popliteal artery and three-vessel runoff to the foot with dampened monophasic waveforms throughout.The subject did not have any significant symptoms; therefore, treatment was deferred at that time.On (b)(6) 2024, the subject visited the hospital for follow up with complaints of having left lower extremity claudication symptoms consistent with rutherford category 1 claudication.The subject reported experiencing worsening left lower extremity claudication and numbness which resolved with rest.The subject was recommended to undergo left lower extremity angiogram with possible intervention on a later date.On (b)(6) 2024, the subject visited the hospital for planned peripheral angiography with possible intervention.On the same day, left lower extremity angiography revealed 50 to 75% stenosis in the proximal sfa and greater than 95% in-stent restenosis of the left sfa and proximal popliteal artery stent with a three-vessel run-off to the foot.On the same day, the in-stent restenosis noted from the left mid sfa and left distal sfa and left proximal popliteal artery were treated by atherectomy device followed by drug coated balloon angioplasty using 6mm x150mm drug coated balloon.The 50-75% stenosis in the left proximal sfa was treated by drug coated balloon angioplasty using 6mm x 60mm balloon.Final angiography demonstrated excellent flow through patent native and stented left femoropopliteal segment leading to a three-vessel runoff to the foot.On the same day, the subject was discharged from the hospital in stable condition.
Additional Manufacturer Narrative
A2: patient age: 76 years old (at the time of enrollment).
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 mid superficial femoral artery (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) 2024, the subject visited the hospital for follow up and underwent bilateral lower extremity arterial doppler ultrasound which revealed: left lower extremity (target limb) new probable in-stent restenosis throughout the sfa stent, with multifocal stenoses leading to a patent popliteal artery and three-vessel runoff to the foot with dampened monophasic waveforms throughout.The subject did not have any significant symptoms; therefore, treatment was deferred at that time.On (b)(6) 2024, the subject visited the hospital for follow up with complaints of having left lower extremity claudication symptoms consistent with rutherford category 1 claudication.The subject reported experiencing worsening left lower extremity claudication and numbness which resolved with rest.The subject was recommended to undergo left lower extremity angiogram with possible intervention on a later date.On (b)(6) 2024, the subject visited the hospital for planned peripheral angiography with possible intervention.On the same day, left lower extremity angiography revealed 50 to 75% stenosis in the proximal sfa and greater than 95% in-stent restenosis of the left sfa and proximal popliteal artery stent with a three-vessel run-off to the foot.On the same day, the in-stent restenosis noted from the left mid sfa and left distal sfa and left proximal popliteal artery were treated by atherectomy device followed by drug coated balloon angioplasty using 6mm x150mm drug coated balloon.The 50-75% stenosis in the left proximal sfa was treated by drug coated balloon angioplasty using 6mm x 60mm balloon.Final angiography demonstrated excellent flow through patent native and stented left femoropopliteal segment leading to a three-vessel runoff to the foot.On the same day, the subject was discharged from the hospital in stable condition.It was further reported that the target lesion #001 was in the left proximal sfa, left mid sfa, and left distal sfa.On (b)(6) 2024, in-stent restenosis was also noted in the left proximal sfa.The previously reported treatment by drug coated balloon angioplasty was done by using 6mm x 60mm and 6mm x 150 mm drug coated balloons.On the same day, the event was considered to be resolved.
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 mid superficial femoral artery (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) 2024, the subject visited the hospital for follow up and underwent bilateral lower extremity arterial doppler ultrasound which revealed: left lower extremity (target limb) new probable in-stent restenosis throughout the sfa stent, with multifocal stenoses leading to a patent popliteal artery and three-vessel runoff to the foot with dampened monophasic waveforms throughout.The subject did not have any significant symptoms; therefore, treatment was deferred at that time.On (b)(6) 2024, the subject visited the hospital for follow up with complaints of having left lower extremity claudication symptoms consistent with rutherford category 1 claudication.The subject reported experiencing worsening left lower extremity claudication and numbness which resolved with rest.The subject was recommended to undergo left lower extremity angiogram with possible intervention on a later date.On (b)(6) 2024, the subject visited the hospital for planned peripheral angiography with possible intervention.On the same day, left lower extremity angiography revealed 50 to 75% stenosis in the proximal sfa and greater than 95% in-stent restenosis of the left sfa and proximal popliteal artery stent with a three-vessel run-off to the foot.On the same day, the in-stent restenosis noted from the left mid sfa and left distal sfa and left proximal popliteal artery were treated by atherectomy device followed by drug coated balloon angioplasty using 6mm x150mm drug coated balloon.The 50-75% stenosis in the left proximal sfa was treated by drug coated balloon angioplasty using 6mm x 60mm balloon.Final angiography demonstrated excellent flow through patent native and stented left femoropopliteal segment leading to a three-vessel runoff to the foot.On the same day, the subject was discharged from the hospital in stable condition.It was further reported that the target lesion #001 was in the left proximal sfa, left mid sfa, and left distal sfa.On (b)(6) 2024, in-stent restenosis was also noted in the left proximal sfa.The previously reported treatment by drug coated balloon angioplasty was done by using 6mm x 60mm and 6mm x 150 mm drug coated balloons.On the same day, the event was considered to be resolved.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.

• 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: 22100994
• Report Number: 2124215-2025-32429
• Device Sequence Number: 7357094
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2025

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: 05/02/2025
• Supplement Date Received by Manufacturer: 06/02/2025; 06/05/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/05/2025; 06/23/2025
• 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