MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA?; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	H74939294600810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical study it was reported that restenosis occurred, requiring revascularization.On (b)(6) 2022, the subject underwent treatment with this 6x80, 130 cm eluvia drug-eluting vascular stent system and a ranger drug coated balloon as part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa, extending up to right distal sfa with 5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length 200 mm with 100% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study device, atherectomy was performed, and pre-dilation was performed by using a 3 mm x 25 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon, a 4 mm x 220 mm pta balloon, a 5 mm x 200 mm pta balloon, and a 5 mm x 120 mm pta balloon.Treatment of the target lesion was then performed by dilation using the study devices, a 6 mm x 200 mm ranger drug coated balloon, and this 6 mm x 80 mm eluvia drug eluting stent.Post-dilation was performed using a 5 mm x 60 mm pta balloon, and the final residual stenosis was noted to be 10%.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.On 18-may-2023, the subject was referred for bilateral lower extremity arterial duplex due to claudication and history of right sfa stent left iliac stent.Bilateral lower extremity arterial duplex was performed which revealed on the right side: more than 75% stenosis the proximal sfa, and calcification in external iliac, common femoral, mid-sfa and distal sfa, deep femoral, popliteal, posterior tibial, peroneal, anterior tibial and dorsalis pedis which was consistent with less than 50% stenosis.On (b)(6) 2023, the subject presented to the hospital for peripheral angiogram and possible intervention of the right lower extremity due to complaints of progressively worsening right leg pain for the past one year.On the same day, abdominal aortogram revealed mild atherosclerotic changes of the distal abdominal aorta with no significant obstructive disease, the right ileo-femoral artery system was patent with no significant disease, patent right internal iliac artery, left common iliac artery stent was patent with no angiographic evidence of restenosis, patent left external iliac artery with no significant disease, occluded left internal iliac artery.Selective angiography of the right lower extremity revealed patent common femoral artery with no significant obstructive disease, occluded proximal sfa, occluded sfa at distal segment, patent deep femoral artery and extensive collaterals that reconstitute the right popliteal artery with three-vessel run off to the periphery.On the same day, occlusion noted in the right proximal sfa, right mid-sfa, and right distal sfa.These were treated using atherectomy and thrombectomy devices followed by dilation using balloon and drug coated balloon.Post treatment, the final residual stenosis was noted to be 5%.On the same day, the event was considered to be resolved.
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).A2 patient age: 66 years old at time of enrollment.
Event or Problem Description
Elegance clinical study.It was reported that restenosis occurred, requiring revascularization.On (b)(6) 2022, the subject underwent treatment with this 6x80, 130 cm eluvia drug-eluting vascular stent system and a ranger drug coated ballon as part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa, extending up to right distal sfa with 5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length 200 mm with 100% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study device, atherectomy was performed, and pre-dilation was performed by using a 3 mm x 25 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon, a 4 mm x 220 mm pta balloon, a 5 mm x 200 mm pta balloon, and a 5 mm x 120 mm pta balloon.Treatment of the target lesion was then performed by dilation using the study devices, a 6 mm x 200 mm ranger drug coated balloon, and this 6 mm x 80 mm eluvia drug eluting stent.Post-dilation was performed using a 5 mm x 60 mm pta balloon, and the final residual stenosis was noted to be 10%.On 10-aug-2022, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject was referred for bilateral lower extremity arterial duplex due to claudication and history of right sfa stent left iliac stent.Bilateral lower extremity arterial duplex was performed which revealed on the right side: more than 75% stenosis the proximal sfa, and calcification in external iliac, common femoral, mid-sfa and distal sfa, deep femoral, popliteal, posterior tibial, peroneal, anterior tibial and dorsalis pedis which was consistent with less than 50% stenosis.On (b)(6) 2023, the subject presented to the hospital for peripheral angiogram and possible intervention of the right lower extremity due to complaints of progressively worsening right leg pain for the past one year.On the same day, abdominal aortogram revealed mild atherosclerotic changes of the distal abdominal aorta with no significant obstructive disease, the right ileo-femoral artery system was patent with no significant disease, patent right internal iliac artery, left common iliac artery stent was patent with no angiographic evidence of restenosis, patent left external iliac artery with no significant disease, occluded left internal iliac artery.Selective angiography of the right lower extremity revealed patent common femoral artery with no significant obstructive disease, occluded proximal sfa, occluded sfa at distal segment, patent deep femoral artery and extensive collaterals that reconstitute the right popliteal artery with three-vessel run off to the periphery.On the same day, occlusion noted in the right proximal sfa, right mid-sfa, and right distal sfa.These were treated using atherectomy and thrombectomy devices followed by dilation using balloon and drug coated balloon.Post treatment, the final residual stenosis was noted to be 5%.On the same day, the event was considered to be resolved.It was further reported that the target lesion was additionally in the right ostial superficial femoral artery (sfa) with lesion length 260mm.The lesion was treated with study devices 6 mm x 200 mm ranger drug coated balloon, and 6 mm x 80 mm eluvia drug eluting stent.On 16-nov-2023, occlusion was noted in the right ostial sfa.It was unknown whether the right ostial sfa was treated during the previously reported revascularization.
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).A2 patient age: 66 years old at time of enrollment.
Additional Manufacturer Narrative
A2 patient age: 66 years old at time of enrollment.
Event or Problem Description
It was reported that restenosis occurred, requiring revascularization.On (b)(6) 2022, the subject underwent treatment with this 6x80, 130 cm eluvia drug-eluting vascular stent system and a ranger drug coated ballon as part of a clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa, extending up to right distal sfa with 5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length 200 mm with 100% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study device, atherectomy was performed, and pre-dilation was performed by using a 3 mm x 25 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon, a 4 mm x 220 mm pta balloon, a 5 mm x 200 mm pta balloon, and a 5 mm x 120 mm pta balloon.Treatment of the target lesion was then performed by dilation using the study devices, a 6 mm x 200 mm ranger drug coated balloon, and this 6 mm x 80 mm eluvia drug eluting stent.Post-dilation was performed using a 5 mm x 60 mm pta balloon, and the final residual stenosis was noted to be 10%.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject was referred for bilateral lower extremity arterial duplex due to claudication and history of right sfa stent left iliac stent.Bilateral lower extremity arterial duplex was performed which revealed on the right side: more than 75% stenosis the proximal sfa, and calcification in external iliac, common femoral, mid-sfa and distal sfa, deep femoral, popliteal, posterior tibial, peroneal, anterior tibial and dorsalis pedis which was consistent with less than 50% stenosis.On (b)(6) 2023, the subject presented to the hospital for peripheral angiogram and possible intervention of the right lower extremity due to complaints of progressively worsening right leg pain for the past one year.On the same day, abdominal aortogram revealed mild atherosclerotic changes of the distal abdominal aorta with no significant obstructive disease, the right ileo-femoral artery system was patent with no significant disease, patent right internal iliac artery, left common iliac artery stent was patent with no angiographic evidence of restenosis, patent left external iliac artery with no significant disease, occluded left internal iliac artery.Selective angiography of the right lower extremity revealed patent common femoral artery with no significant obstructive disease, occluded proximal sfa, occluded sfa at distal segment, patent deep femoral artery and extensive collaterals that reconstitute the right popliteal artery with three-vessel run off to the periphery.On the same day, occlusion noted in the right proximal sfa, right mid-sfa, and right distal sfa.These were treated using atherectomy and thrombectomy devices followed by dilation using balloon and drug coated balloon.Post treatment, the final residual stenosis was noted to be 5%.On the same day, the event was considered to be resolved.It was further reported that the target lesion was additionally in the right ostial superficial femoral artery (sfa) with lesion length 260mm.The lesion was treated with study devices 6 mm x 200 mm ranger drug coated balloon, and 6 mm x 80 mm eluvia drug eluting stent.On (b)(6) 2023, occlusion was noted in the right ostial sfa.It was unknown whether the right ostial sfa was treated during the previously reported revascularization.It was further reported that on (b)(6) 2023, the subject presented to the hospital for peripheral angiogram and possible intervention of the right lower extremity due to complaints of progressively worsening right leg pain.Physical examination of the lower extremity revealed faint bilateral pulses and bruits.The previously reported information regarding the abdominal aortogram was removed.Additionally, on (b)(6) 2023, selective angiography of the right lower extremity performed revealed patent common femoral artery with no significant obstructive disease, occluded proximal sfa, in-stent occlusion of the distal sfa, patent deep femoral artery and extensive collaterals that reconstitute the right popliteal artery with three-vessel run off to the periphery.

• 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: 18318434
• Report Number: 2124215-2023-65708
• Device Sequence Number: 20402931
• Product Code: NIU
• UDI-Device Identifier: 08714729876595
• UDI-Public: (01)08714729876595(17)230806(10)27963184
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/22/2025

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: 08/06/2023
• Device Model Number: H74939294600810
• Device Catalogue Number: H74939294600810
• Device Lot Number: 0027963184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 09/11/2024; 04/02/2025
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 10/03/2024; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JETSTREAM, STERLING PTA, RANGER DCB; JETSTREAM, STERLING PTA, RANGER DCB; JETSTREAM, STERLING PTA, RANGER DCB
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American