MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number PLC231400

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Material Separation (1562); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses featuring c3® delivery system.After successful deployment of the trunk-ipsilateral leg component, there was reported difficulty advancing the contralateral leg component into the contralateral gate.The graft was advanced outside of the sheath and rotated in an attempt to advance the endoprosthesis into the contralateral gate.Next, the device was forcefully pulled distally and again rotated in an effort to cannulate the gate.At this point it was noted the proximal 4-5 cm of the device had prematurely deployed distal to the contralateral gate.The decision was made to deploy the rest of the device where it was and an additional contralateral leg component was implanted to bridge the trunk-ipsilateral leg and contralateral leg components.After removal of the delivery catheter it was observed that the leading olive and part of the polyimide guidewire lumen had completely separated from the delivery catheter.Intra-operative imaging reported the leading olive and polyimide guidewire lumen now appeared to be ¿free floating¿ within the patient¿s mid-thoracic aorta.It is believed that during ballooning of the device the guidewire and balloon had pushed the leading olive and polyimide more proximally.A snare catheter was used to retrieve the detached olive and polyimide guidewire lumen from inside the patient.The procedure concluded without any further complications, and the patient tolerated the procedure.

Manufacturer Narrative

Evaluation summary - the contralateral leg component was returned to gore for evaluation.The device was returned with the leading end of the delivery catheter fractured at the trailing olive.An investigation of the leading olive showed no damage.During the investigation it was observed that the polyimide guidewire lumen was kinked at the leading end of the catheter and had been pulled out at the trailing olive.The findings are consistent with the reported observations.Based on the available information and evaluation of the returned product, no root cause for the difficulty to advance the device, for the premature deployment of the endoprosthesis and for the broken leading end of the catheter could be determined with the currently available information.However, use outside of the gore® excluder® aaa endoprosthesis instruction for use may have contributed to this event.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4164661
• MDR Text Key: 4870481
• Report Number: 3007284313-2014-00095
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2014

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: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: PLC231400
• Device Lot Number: 12743274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2014
• Date Device Manufactured: 07/10/2014
• 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: 80 YR