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	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
(b)(6) study.It was reported that dissection occurred.The subject underwent treatment with the ranger drug coated balloon, and two eluvia drug eluting stents on (b)(6) 2021 as a part of the elegance clinical trial.The first target lesion was in the entire length of left sfa (proximal, mid, distal sfa) extending into left proximal popliteal artery with proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 4.5 mm with lesion length of 360 m and 100% stenosis.Pre-dilatation was performed, and treatment of target lesion was performed by dilatation with study devices, ranger drug coated balloon 5 mm x 150 mm and eluvia drug eluting stents of sizes 6 mm x 120 mm and 6 mm x 100 mm were implanted.Post target lesion treatment was done by stenting with non-bsc drug eluting stent due to dissection of grade e and residual stenosis noted.Following post treatment, the final residual stenosis was noted to be 20%.The complication was considered to be resolved.On (b)(6) 2021, the subject was discharged from the hospital.
Event or Problem Description
Elegance clinical study.It was reported that dissection occurred.The subject underwent treatment with the ranger drug coated balloon, and two eluvia drug eluting stents on (b)(6) 2021 as a part of the elegance clinical trial.The first target lesion was in the entire length of left sfa (proximal, mid, distal sfa) extending into left proximal popliteal artery with proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 4.5 mm with lesion length of 360 m and 100% stenosis.Pre-dilatation was performed, and treatment of target lesion was performed by dilatation with study devices, ranger drug coated balloon 5 mm x 150 mm and eluvia drug eluting stents of sizes 6 mm x 120 mm and 6 mm x 100 mm were implanted.Post target lesion treatment was done by stenting with non-bsc drug eluting stent due to dissection of grade e and residual stenosis noted.Following post treatment, the final residual stenosis was noted to be 20%.The complication was considered to be resolved.On (b)(6) 2021, the subject was discharged from the hospital.It was further reported that during or after index procedure, the subject was noted with complication of dissection with severity grade e due to a non-bsc device.Subsequently, the subject was treated with bailout stent non-bsc drug eluting stent of size 4.5 mm x 100 mm and the complication was considered resolved.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 12558896
• Report Number: 2134265-2021-12114
• Device Sequence Number: 16477638
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• Combination Product (Y/N): Y
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 11/10/2022

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: 03/10/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027040255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Race: White