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 Code	Vascular Dissection (3160)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
(b)(6) study.It was reported that vessel dissection occurred.The subject underwent treatment with the eluvia drug eluting stent on (b)(6) 2021 as a part of the elegance clinical trial.The first target lesion was in the right distal superficial femoral artery extending to right proximal popliteal artery with proximal reference vessel diameter of 5.5 mm and distal reference vessel diameter of 5.5 mm with lesion length of 100 mm and 100% stenosis and was classified as tasc ii b lesion.Treatment of first target lesion was performed by placement of study device, eluvia drug eluting stent of 6.0 mm x 120 mm.Post treatment final residual stenosis was noted to be 5%.The second target lesion was in the right proximal superficial femoral artery extending to right mid superficial femoral artery with proximal reference vessel diameter of 5.5 mm and distal reference vessel diameter of 5.5 mm with lesion length of 80 mm and 90% stenosis and was classified as tasc ii b lesion.Treatment of second target lesion was performed by placement of study device; eluvia drug eluting stent of 6.0 mm x 100 mm.Post treatment final residual stenosis was noted to be 5%.On (b)(6) 2021, on the same day of index procedure, during treatment of the target lesions, dissection of grade b was noted.In response to the event, balloon dilation was performed, and bailout stent was implanted.Post treatment final residual stenosis was noted to be 5%.The complication was resolved, and the subject was discharged from the hospital on aspirin.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2: age at time of event: 77 years old.
Event or Problem Description
Elegance study.It was reported that vessel dissection occurred.The subject underwent treatment with the eluvia drug eluting stent on october 12, 2021 as a part of the elegance clinical trial.The first target lesion was in the right distal superficial femoral artery extending to right proximal popliteal artery with proximal reference vessel diameter of 5.5 mm and distal reference vessel diameter of 5.5 mm with lesion length of 100 mm and 100% stenosis and was classified as tasc ii b lesion.Treatment of first target lesion was performed by placement of study device, eluvia drug eluting stent of 6.0 mm x 120 mm.Post treatment final residual stenosis was noted to be 5%.The second target lesion was in the right proximal superficial femoral artery extending to right mid superficial femoral artery with proximal reference vessel diameter of 5.5 mm and distal reference vessel diameter of 5.5 mm with lesion length of 80 mm and 90% stenosis and was classified as tasc ii b lesion.Treatment of second target lesion was performed by placement of study device; eluvia drug eluting stent of 6.0 mm x 100 mm.Post treatment final residual stenosis was noted to be 5%.On october 12, 2021, on the same day of index procedure, during treatment of both target lesions, dissection of grade b was noted.In response to the event, balloon dilation was performed, and bailout stent was implanted.Post treatment final residual stenosis was noted to be 5%.The complication was resolved, and the subject was discharged from the hospital on aspirin.It was further reported that the dissection noted in the first target lesion was caused by the 5 mm x 100 mm sterling balloon.The site has confirmed that dissection noted in the second target lesion was caused by a sterling balloon as well.

• 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: 14048309
• Report Number: 2134265-2022-03778
• Device Sequence Number: 5881315
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 07/15/2022

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: 04/21/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027384037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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 Sex: Female
• Patient Race: Black Or African American