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 Thrombosis (2100)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

This is a combination device.Age at time of event: subject was (b)(6) years old at the time of enrollment.

Event Description

(b)(6) study.It was reported that stent thrombosis occurred.The subject was enrolled in (b)(6) study on (b)(6) 2017 and the index procedure was performed on the same day.Target lesion was located in left distal superficial femoral artery (sfa) with 95% stenosis and was 60 mm long with a proximal and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilation which was followed by placement of a 6 mm x 80 mm study stent.Following post dilation, residual stenosis was at 0%.Subject was treated on out-patient basis.On (b)(6) 2018, 342 days post index procedure, subject presented to the enrolling site for the 12-month follow-up visit.Duplex ultrasound was performed which revealed stent occlusion.Rutherford category assessed on the same day was at 2 (moderate claudication).On (b)(6) 2019, 486 days post index procedure, the subject was hospitalized for the further evaluation and treatment.On the same day a surgical procedure of femoral to popliteal artery bypass was performed using venous graft.On (b)(6) 2019, subject was discharged.On (b)(6) 2019, 731 days post index procedure the event was considered to be recovered/ resolved.Of note, he site has been queried for resolution date, as subject was discharged on (b)(6) 2019 and event was resolved 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: 10079385
• MDR Text Key: 191711404
• Report Number: 2134265-2020-06800
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019580095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• 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