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	Pain (1994); Numbness (2415); Restenosis (4576)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 patient age: 60 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 6x120, 130 cm eluvia stent as 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 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 260 mm lesion length with 100% stenosis and was classified as transatlantic intersociety consensus (tasc) ii class c lesion.Prior to target lesion treatment with the study device, pre-dilation was performed using 3 mm x 40 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon, and 5 mm x 220 mm pta balloon.Treatment of the target lesion was performed by placement of 6 mm x 150 mm, 6 mm x 120 mm and 6 mm x 80 mm eluvia drug eluting stents, study devices.Following treatment was performed by dilation using 6 mm x 220 mm pta balloon.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 with complaints of severe left leg pain with walking 1 block which had worsened over the past month.The subject also reported occasional numbness in the left foot which improved after movement and rutherford assessment revealed category 3 claudication in left leg.On (b)(6) 2024, the subject was admitted to the hospital for planned angiogram with possible intervention.The subject was noted to have severe peripheral artery disease with in-stent restenosis of the left distal common femoral artery to left proximal superficial femoral artery.On the same day, 65% in-stent restenosis was noted in the left distal common femoral artery and left proximal sfa and was treated by balloon angioplasty using cutting balloon and drug coated balloon.Post procedure, the final residual stenosis was noted to be 0%.On (b)(6) 2024, the subject was discharged from the hospital on aspirin and plavix.
Event or Problem Description
It was reported that restenosis occurred, requiring intervention.On (b)(6) 2023 the subject underwent treatment with this 6x120, 130 cm eluvia stent as 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 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 260 mm lesion length with 100% stenosis and was classified as transatlantic intersociety consensus (tasc) ii class c lesion.Prior to target lesion treatment with the study device, pre-dilation was performed using 3 mm x 40 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon, and 5 mm x 220 mm pta balloon.Treatment of the target lesion was performed by placement of 6 mm x 150 mm, 6 mm x 120 mm and 6 mm x 80 mm eluvia drug eluting stents, study devices.Following treatment was performed by dilation using 6 mm x 220 mm pta balloon.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 with complaints of severe left leg pain with walking 1 block which had worsened over the past month.The subject also reported occasional numbness in the left foot which improved after movement and rutherford assessment revealed category 3 claudication in left leg.On (b)(6) 2024, the subject was admitted to the hospital for planned angiogram with possible intervention.The subject was noted to have severe peripheral artery disease with in-stent restenosis of the left distal common femoral artery to left proximal superficial femoral artery.On the same day, 65% in-stent restenosis was noted in the left distal common femoral artery and left proximal sfa and was treated by balloon angioplasty using cutting balloon and drug coated balloon.Post procedure, the final residual stenosis was noted to be 0%.On (b)(6) 2024, the subject was discharged from the hospital on aspirin and plavix.It was further reported that on (b)(6) 2024, bilateral lower extremity angiography revealed: left lower extremity (target limb): minimal luminal irregularities in common iliac artery and external iliac artery; 90% stenosis from distal common femoral artery to proximal superficial femoral artery; 30% stenosis from proximal sfa to distal sfa; 60% stenosis in distal sfa; mild diffuse disease throughout the popliteal artery with 55% stenosis in mid popliteal artery; 30% stenosis from proximal to mid portion of anterior tibial artery; 40% stenosis in tibioperoneal trunk; 30% stenosis from proximal to mid portion of posterior tibial artery.On (b)(6) 2024, 354 days post index procedure, 90% in-stent restenosis was noted from the left distal common femoral artery to left proximal sfa and was treated by balloon angioplasty using 6mm x 20mm peripheral cutting balloon and 6mm x 40mm inpact drug coated balloon.Final angiography demonstrated brisk flow with no evidence of flow-limiting dissection or perforation.
Additional Manufacturer Narrative
A2 patient age: 60 years old (at the time of enrollment).
Additional Manufacturer Narrative
A2 patient age: 60 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 6x120, 130 cm eluvia stent as 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 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 260 mm lesion length with 100% stenosis and was classified as transatlantic intersociety consensus (tasc) ii class c lesion.Prior to target lesion treatment with the study device, pre-dilation was performed using 3 mm x 40 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon, and 5 mm x 220 mm pta balloon.Treatment of the target lesion was performed by placement of 6 mm x 150 mm, 6 mm x 120 mm and 6 mm x 80 mm eluvia drug eluting stents, study devices.Following treatment was performed by dilation using 6 mm x 220 mm pta balloon.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 with complaints of severe left leg pain with walking 1 block which had worsened over the past month.The subject also reported occasional numbness in the left foot which improved after movement and rutherford assessment revealed category 3 claudication in left leg.On (b)(6) 2024, the subject was admitted to the hospital for planned angiogram with possible intervention.The subject was noted to have severe peripheral artery disease with in-stent restenosis of the left distal common femoral artery to left proximal superficial femoral artery.On the same day, 65% in-stent restenosis was noted in the left distal common femoral artery and left proximal sfa and was treated by balloon angioplasty using cutting balloon and drug coated balloon.Post procedure, the final residual stenosis was noted to be 0%.On (b)(6) 2024, the subject was discharged from the hospital on aspirin and plavix.It was further reported that on (b)(6) 2024, bilateral lower extremity angiography revealed: left lower extremity (target limb): minimal luminal irregularities in common iliac artery and external iliac artery; 90% stenosis from distal common femoral artery to proximal superficial femoral artery; 30% stenosis from proximal sfa to distal sfa; 60% stenosis in distal sfa; mild diffuse disease throughout the popliteal artery with 55% stenosis in mid popliteal artery; 30% stenosis from proximal to mid portion of anterior tibial artery; 40% stenosis in tibioperoneal trunk; 30% stenosis from proximal to mid portion of posterior tibial artery.On (b)(6) 2024, 354 days post index procedure, 90% in-stent restenosis was noted from the left distal common femoral artery to left proximal sfa and was treated by balloon angioplasty using 6mm x 20mm peripheral cutting balloon and 6mm x 40mm inpact drug coated balloon.Final angiography demonstrated brisk flow with no evidence of flow-limiting dissection or perforation.It was further reported that on (b)(6) 2023 the target lesion #001 was also in the left ostial superficial femoral artery.
Event or Problem Description
It was reported that restenosis occurred, requiring intervention.On (b)(6) 2023 the subject underwent treatment with this 6x120, 130 cm eluvia stent as 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 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 260 mm lesion length with 100% stenosis and was classified as transatlantic inter society consensus (tasc) ii class c lesion.Prior to target lesion treatment with the study device, pre-dilation was performed using 3 mm x 40 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon, and 5 mm x 220 mm pta balloon.Treatment of the target lesion was performed by placement of 6 mm x 150 mm, 6 mm x 120 mm and 6 mm x 80 mm eluvia drug eluting stents, study devices.Following treatment was performed by dilation using 6 mm x 220 mm pta balloon.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 with complaints of severe left leg pain with walking 1 block which had worsened over the past month.The subject also reported occasional numbness in the left foot which improved after movement and rutherford assessment revealed category 3 claudication in left leg.On (b)(6) 2024, the subject was admitted to the hospital for planned angiogram with possible intervention.The subject was noted to have severe peripheral artery disease with in-stent restenosis of the left distal common femoral artery to left proximal superficial femoral artery.On the same day, 65% in-stent restenosis was noted in the left distal common femoral artery and left proximal sfa and was treated by balloon angioplasty using cutting balloon and drug coated balloon.Post procedure, the final residual stenosis was noted to be 0%.On (b)(6) 2024, the subject was discharged from the hospital on aspirin and plavix.It was further reported that on (b)(6) 2024, bilateral lower extremity angiography revealed: left lower extremity (target limb): minimal luminal irregularities in common iliac artery and external iliac artery; 90% stenosis from distal common femoral artery to proximal superficial femoral artery; 30% stenosis from proximal sfa to distal sfa; 60% stenosis in distal sfa; mild diffuse disease throughout the popliteal artery with 55% stenosis in mid popliteal artery; 30% stenosis from proximal to mid portion of anterior tibial artery; 40% stenosis in tibioperoneal trunk; 30% stenosis from proximal to mid portion of posterior tibial artery.On (b)(6) 2024, 354 days post index procedure, 90% in-stent restenosis was noted from the left distal common femoral artery to left proximal sfa and was treated by balloon angioplasty using 6mm x 20mm peripheral cutting balloon and 6mm x 40mm impact drug coated balloon.Final angiography demonstrated brisk flow with no evidence of flow-limiting dissection or perforation.It was further reported that on (b)(6) 2023 the target lesion # 001 was also in the left ostial superficial femoral artery.
Additional Manufacturer Narrative
A2 patient age: 60 years old (at the time of enrollment).

• 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: 22132235
• Report Number: 2124215-2025-34444
• Device Sequence Number: 7424853
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: (01)08714729876618(17)240927(10)30413410
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 01/22/2026

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: 12/01/2024
• Device Model Number: H74939294601510
• Device Catalogue Number: H74939294601510
• Device Lot Number: 0030838080
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 11/17/2025; 12/31/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 09/09/2025; 12/02/2025; 01/22/2026
• Date Device Manufactured: 12/02/2022
• 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: Female
• Patient Ethnicity: Hispanic