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	Ischemia (1942); Unspecified Tissue Injury (4559); Restenosis (4576)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical study.It was reported that restenosis occurred, requiring intervention.On (b)(6) 2023, the subject underwent treatment with two 6x120, 130 cm eluvia drug-eluting vascular stents as a part of the elegance clinical trial.The target lesion was located in the left proximal superficial femoral artery (sfa), left mid sfa, extending up to the left distal sfa with 5.5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length 230 mm, with 100% stenosis and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study devices, pre-dilation was performed using 4 mm x 220 mm sterling over-the-wire percutaneous transluminal angioplasty balloon.Treatment of the target lesion was then performed by placement of these two 6 mm x 120 mm eluvia drug eluting stents study devices.Post-dilation was performed using 5 mm x 120 mm sterling over-the-wire pta balloon and the final residual stenosis was noted to be 30%.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject was admitted to the hospital for reintervention of left lower extremity peripheral arterial occlusive disease.The subject was diagnosed with left lower extremity chronic limb threatening ischemia with minor tissue loss, with prior hybrid intervention.Subsequently, during the operative procedure, the subject underwent angiography which revealed new severe stenosis of the left proximal sfa.On the same day, 80% severe restenosis was found in the left proximal sfa and was treated by pre-dilation using 4.5 mm x 40 mm sterling balloon followed by drug coated balloon angioplasty using 6 mm x 40 mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 30% with no evidence of dissection and preserved runoff to the left foot.On 14-nov-2023, the event was considered resolved and the subject was discharged from the hospital as subject was deemed medically stable for discharge.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: patient age: 74 years old at time of enrollment.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: patient age: 74 years old at time of enrollment.
Event or Problem Description
Elegance clinical study: it was reported that restenosis occurred, requiring intervention.On (b)(6) 2023, the subject underwent treatment with two 6x120, 130 cm eluvia drug-eluting vascular stents as a part of the elegance clinical trial.The target lesion was located in the left proximal superficial femoral artery (sfa), left mid sfa, extending up to the left distal sfa with 5.5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length 230 mm, with 100% stenosis and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study devices, pre-dilation was performed using 4 mm x 220 mm sterling over-the-wire percutaneous transluminal angioplasty balloon.Treatment of the target lesion was then performed by placement of these two 6 mm x 120 mm eluvia drug eluting stents study devices.Post-dilation was performed using 5 mm x 120 mm sterling over-the-wire pta balloon and the final residual stenosis was noted to be 30%.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject was admitted to the hospital for reintervention of left lower extremity peripheral arterial occlusive disease.The subject was diagnosed with left lower extremity chronic limb threatening ischemia with minor tissue loss, with prior hybrid intervention.Subsequently, during the operative procedure, the subject underwent angiography which revealed new severe stenosis of the left proximal sfa.On the same day, 80% severe restenosis was found in the left proximal sfa and was treated by pre-dilation using 4.5 mm x 40 mm sterling balloon followed by drug coated balloon angioplasty using 6 mm x 40 mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 30% with no evidence of dissection and preserved runoff to the left foot.On (b)(6) 2023, the event was considered resolved and the subject was discharged from the hospital as subject was deemed medically stable for discharge.It was further reported that the restenosis was due to only one of the 6x120, 130 cm eluvia drug-eluting vascular stents.
Additional Manufacturer Narrative
A2: patient age: 74 years old at time of enrollment.
Event or Problem Description
It was reported that restenosis occurred, requiring intervention.On (b)(6) 2023, the subject underwent treatment with two 6x120, 130 cm eluvia drug-eluting vascular stents as a part of a clinical trial.The target lesion was located in the left proximal superficial femoral artery (sfa), left mid sfa, extending up to the left distal sfa with 5.5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length 230 mm, with 100% stenosis and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study devices, pre-dilation was performed using 4 mm x 220 mm sterling over-the-wire percutaneous transluminal angioplasty balloon.Treatment of the target lesion was then performed by placement of these two 6 mm x 120 mm eluvia drug eluting stents study devices.Post-dilation was performed using 5 mm x 120 mm sterling over-the-wire pta balloon and the final residual stenosis was noted to be 30%.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject was admitted to the hospital for reintervention of left lower extremity peripheral arterial occlusive disease.The subject was diagnosed with left lower extremity chronic limb threatening ischemia with minor tissue loss, with prior hybrid intervention.Subsequently, during the operative procedure, the subject underwent angiography which revealed new severe stenosis of the left proximal sfa.On the same day, 80% severe restenosis was found in the left proximal sfa and was treated by pre-dilation using 4.5 mm x 40 mm sterling balloon followed by drug coated balloon angioplasty using 6 mm x 40 mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 30% with no evidence of dissection and preserved runoff to the left foot.On (b)(6) 2023, the event was considered resolved and the subject was discharged from the hospital as subject was deemed medically stable for discharge.It was further reported that the restenosis was due to only one of the 6x120, 130 cm eluvia drug-eluting vascular stents.It was further reported that on (b)(6) 2023, post treatment, the final residual stenosis was noted to be 0%.

• 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: 19632987
• Report Number: 2124215-2024-35289
• Device Sequence Number: 21031091
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: (01)08714729876618(17)240427(10)29488202
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 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: 04/27/2024
• Device Model Number: H74939294601210
• Device Catalogue Number: H74939294601210
• Device Lot Number: 0029488202
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 04/17/2025
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/30/2024; 04/22/2025
• Date Device Manufactured: 04/28/2022
• 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: ELUVIA, RANGER, EPIC, STERLING; ELUVIA, RANGER, EPIC, STERLING; ELUVIA, RANGER, EPIC, STERLING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American