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 Problem Reocclusion (1985)

Event Date 11/28/2019

Event Type  Injury  

Event Description

It was reported that restenosis occurred.The subject was enrolled in the eminent study on (b)(6) 2017 and the index procedure was performed on the same day.Target lesion was located in left mid sfa with 100% stenosis and was 50 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5.3 mm and was classified as tasc ii a lesion.Target lesion was treated with pre-dilation followed by placement of a 7 mm x 60 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2017, the subject was discharged with antiplatelet medications.On (b)(6) 2019, 710 days post index procedure, the subject presented to the enrolling site for the protocol specified 2-year follow-up visit.Rutherford category assessed on the same day was 0 (asymptomatic).Diagnostic tests revealed 70% stenosis of the femoral artery on the left -proximal to the stent.Intervention was planned on a later date.On (b)(6) 2019, the subject was hospitalized for the planned intervention.On (b)(6) 2019, 731 days post index procedure, the 70% stenosis in left proximal and distal sfa was treated with percutaneous transluminal angioplasty (pta) and stenting resulting in 0% final stenosis.On (b)(6) 2019, the event was resolved and the subject was discharged on (b)(6) 2019.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10825284
• MDR Text Key: 215895484
• Report Number: 2134265-2020-15636
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019719930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR