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 Thrombosis (2100); Tingling (2171)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Date of birth: 1957.

Event Description

It was reported that thrombosis of the study stent occurred.The patient underwent treatment with the eluvia device on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the left distal superficial femoral artery (sfa), had a 6mm reference vessel diameter proximally and distally.The lesion had a total length of 40mm.The target lesion was 100% occluded and crossed subintimal.Pre-dilatation was performed using a 5.0 mm balloon after which a 6x100mm eluvia stent was implanted.Post-dilatation was performed using a 5.0mm balloon.Residual stenosis was 40%.On (b)(6) 2019, thrombosis of the left sfa and the study stent was observed.The patient had a prickle sensation in the left leg and sensation of cold in the left toe for two weeks.The patient had a walking distance over 300 meters.Conservative treatment was planned and the event is reported as ongoing.

• 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: 9163351
• MDR Text Key: 161454856
• Report Number: 2134265-2019-11920
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• 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: 0019631130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2016
• 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): Other
• Patient Age: 61 YR