MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. EXCLUDER; PROSTHESIS, VASCULAR GRAFT

Catalog Number PLC271000

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/15/2017

Event Type  malfunction  

Event Description

A surgery for endovascular repair of abdominal aortic aneurysm (aaa) was commencing.Dr.Was inserting a gore-tex aaa endoprosthesis and was having trouble advancing the product.It was visible that part of the device had deployed without engaging it to do so.Eventually, it was placed properly, as was another endoprosthesis.Closure of the femoral vessel was commenced.While the closing continued, the dr.Inspected the pieces of the troublesome endoprosthesis.The doctor discovered that the tip and some of the wire which were supposed to be removed after deployment were missing.A thorough search with imaging equipment showed the tip in the aorta.With another 45 minutes of surgical time and 3 different snares the doctor was able to retrieve the piece.The aorta was re-examined with imaging and deemed intact.The device and all pieces were saved.

• Brand Name: EXCLUDER
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 north fourth st.; flagstaff AZ 86004
• MDR Report Key: 6292261
• MDR Text Key: 66263010
• Report Number: 6292261
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: PLC271000
• Other Device ID Number: 10 CM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR