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	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) clinical study.It was reported that a dissection occurred.The subject underwent treatment with the eluvia drug eluting stent on (b)(6) 2021 as a part of the (b)(6) clinical trial.The target lesion was located in the entire length of right superficial femoral artery extending up to right proximal popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length of 300 mm and 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment, pre-dilation was performed with a 5 mm x 200 mm mustang pta balloon.Treatment of target lesion was performed by placement of one 6.0 mm x 120 mm and, two 6 mm x 100 mm eluvia drug coated study stents.Post dilation was performed with a 5 mm x 200 mm mustang pta balloon.Following post dilation, the final residual stenosis was noted to be 30%.On (b)(6) 2021, during treatment of the target lesion, dissection of severity grade c was noted with residual stenosis of 30%.As a response to the event, bailout stent was implanted followed by balloon dilation was performed, and the complication was resolved.
Additional Manufacturer Narrative
A1.Patient identifier: (b)(6).
Event or Problem Description
Elegance clinical study.It was reported that a 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 target lesion was located in the entire length of right superficial femoral artery extending up to right proximal popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length of 300 mm and 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment, predilation was performed with a 5 mm x 200 mm mustang pta balloon.Treatment of target lesion was performed by placement of one 6.0 mm x 120 mm and, two 6 mm x 100 mm eluvia drug coated study stents.Post dilation was performed with a 5 mm x 200 mm mustang pta balloon.Following post dilation, the final residual stenosis was noted to be 30%.On (b)(6) 2021, during treatment of the target lesion, dissection of severity grade c was noted with residual stenosis of 30%.As a response to the event, bailout stent was implanted followed by balloon dilation was performed, and the complication was resolved.It was further reported that during treatment of the target lesion, dissection of severity grade c was noted after the pre dilation with mustang 5mm x 200mm balloon.As a response to the event, bailout stent was implanted followed by balloon dilation was performed.The dissection occurred prior to use of the three eluvia stents, therefore the event is not related to this device.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12724635
• Report Number: 2134265-2021-13500
• Device Sequence Number: 17107682
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 05/24/2022

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: 10/08/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 05/24/2022
• 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: Unknown