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); Claudication (2550)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: (b)(6) at time of enrollment.

Event Description

(b)(6) study.It was reported that stent thrombosis 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 right mid and distal superficial femoral artery (sfa) with 100% stenosis and was 150 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 c lesion.The target lesion was treated with pre-dilatation followed by placement of 6mm x 120mm and 6mm x 80mm study stents.Following post dilation, residual stenosis was 10%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, the subject presented to the site for protocol scheduled 12-month follow-up visit.On arrival, rutherford classification was 1 (mild claudication) and stent thrombosis was noted.No action has been taken to treat this event.No additional patient complications have been reported.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10514458
• MDR Text Key: 206324097
• Report Number: 2134265-2020-12579
• 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: 09/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023560290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other