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

Model Number	24657
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Paresthesia (4421); Restenosis (4576)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id:(b)(6) patient age: 50 years old at time of enrollment.
Event or Problem Description
Elegance clinical study it was reported that in-stent restenosis occurred, requiring intervention.On (b)(6) 2023, the subject underwent treatment with this 7x60, 130 cm eluvia drug-eluting vascular stent system as a part of the elegance clinical trial.The 90% stenosed target lesion was in the right distal superficial femoral artery (sfa), extending up to the right proximal popliteal artery, with 7 mm proximal reference vessel diameter, and 7 mm distal reference vessel diameter, with lesion length of 40 mm.The lesion was classified as transatlantic intersociety consensus (tasc) ii a lesion.Prior to the treatment of the target lesion with the study device, balloon dilation was performed using a 6.5 mm x 40 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was then performed by placement of this 7 mm x 60 mm eluvia drug eluting stent study device.Following treatment, post-dilation was performed using 7 mm x 20 mm non-boston scientific pta balloon.Post procedure, the final residual stenosis was noted to be 15%.On the same day, the subject was discharged from the hospital on clopidogrel.On 07-mar-2024, the subject visited the hospital for a 6 month follow up visit with complaints of occasional pain, numbness and tingling in right calf and back pain from the prior month.On the same day, arterial examination of the lower extremity revealed evidence suggestive of moderate stenosis in the right sfa stent of 50-74%.The subject was recommended for right leg angiography, pta with laser atherectomy on a later date.On 02-apr-2024, the subject visited the hospital for planned right lower extremity angiogram.On the same day, 75% stenosis was noted in the right distal sfa and right proximal popliteal artery stent, and was treated by laser atherectomy, followed by post-dilation using 7 mm x 60 mm non-boston scientific drug coated balloon.Post treatment, the final residual stenosis was noted to be 15% and good flow was noted throughout the stenosed stent.On the same day, the event was considered resolved.
Additional Manufacturer Narrative
A1: patient id: (b)(6).A2: patient age: 50 years old at time of enrollment.
Event or Problem Description
Elegance clinical study.It was reported that in-stent restenosis occurred, requiring intervention.On (b)(6) 2023, the subject underwent treatment with this 7x60, 130 cm eluvia drug-eluting vascular stent system as a part of the elegance clinical trial.The 90% stenosed target lesion was in the right distal superficial femoral artery (sfa), extending up to the right proximal popliteal artery, with 7 mm proximal reference vessel diameter, and 7 mm distal reference vessel diameter, with lesion length of 40 mm.The lesion was classified as transatlantic intersociety consensus (tasc) ii a lesion.Prior to the treatment of the target lesion with the study device, balloon dilation was performed using a 6.5 mm x 40 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was then performed by placement of this 7 mm x 60 mm eluvia drug eluting stent study device.Following treatment, post-dilation was performed using 7 mm x 20 mm non-boston scientific pta balloon.Post procedure, the final residual stenosis was noted to be 15%.On the same day, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2024, the subject visited the hospital for a 6 month follow up visit with complaints of occasional pain, numbness and tingling in right calf and back pain from the prior month.On the same day, arterial examination of the lower extremity revealed evidence suggestive of moderate stenosis in the right sfa stent of 50-74%.The subject was recommended for right leg angiography, pta with laser atherectomy on a later date.On (b)(6) 2024, the subject visited the hospital for planned right lower extremity angiogram.On the same day, 75% stenosis was noted in the right distal sfa and right proximal popliteal artery stent, and was treated by laser atherectomy, followed by post-dilation using 7 mm x 60 mm non-boston scientific drug coated balloon.Post treatment, the final residual stenosis was noted to be 15% and good flow was noted throughout the stenosed stent.On the same day, the event was considered resolved.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• 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: 19217518
• Report Number: 2124215-2024-21198
• Device Sequence Number: 20859374
• Product Code: NIU
• UDI-Device Identifier: 08714729876700
• UDI-Public: 08714729876700
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 01/06/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028687882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White