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

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 11/23/2020

Event Type  Injury  

Event Description

It was reported that in-stent occlusion occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis and was 100 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation followed by placement of a 6 mm x 100 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, the subject presented to the enrolling site for protocol scheduled 1-year follow-up visit.Diagnostic test revealed that the subject developed in-stent occlusion in the right sfa.Stenting was planned for a later date.During the event, the subject was on clopidogrel and aspirin.

Event Description

It was reported that in-stent occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis and was 100 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation followed by placement of a 6 mm x 100 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, the subject presented to the enrolling site for protocol scheduled 1-year follow-up visit.Diagnostic test revealed that the subject developed in-stent occlusion in the right sfa.Rutherford category on (b)(6) 2020 was 3 (severe claudication).Stenting was planned for a later date.During the event, the subject was on clopidogrel and aspirin.At the time of reporting, outcome of the event is ongoing.It was further reported that there is no revascularization to be performed in the near future.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10960477
• MDR Text Key: 219983768
• Report Number: 2134265-2020-16988
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023179735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR