MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number H74939238700610

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) clinical study.It was reported that a stent fracture occurred.The patient was enrolled in the (b)(6) study in (b)(6) 2016.The target lesion was located in the right leg mid superficial femoral artery (sfa) with 100% stenosis and was 40 mm long with a proximal reference vessel diameter of 6.00 mm and distal vessel diameter of 6.00 mm and was classified as tasc ii a lesion.Target lesion was treated with pre-dilatation and placement of a 7mm x 60mm study stent.Following post-dilatation, residual stenosis was 0%.(b)(6) 2017, 338 days after index procedure, during the 12 month follow up, x-ray was performed which revealed stent fracture in the study stent deployed in the right mid sfa.It was also noted that the patient had a pain-free 6 minute hall walk test.No patient complications were reported.This product is only ous approved but it is similar to an approved us device.

• Brand Name: ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7086114
• MDR Text Key: 94662657
• Report Number: 2134265-2017-11719
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: H74939238700610
• Device Catalogue Number: 39238-70061
• Device Lot Number: 0018334951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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 Age: 70 YR