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

Catalog Number PLC201200J

Device Problems Material Separation (1562); Sticking (1597)

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

Event Date 07/24/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported the devices were implanted with no issues.Upon removal of the delivery catheter of plc201200j, it was reported that the olive got caught at the proximal end of the sheath.The physician reportedly withdrawn the delivery catheter into the sheath, and the olive was completely separated from the rest of the catheter.A snare catheter was used to retrieve the olive from inside the patient.The procedure concluded without any further complications, and the patient tolerated the procedure.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Results pending completion of evaluation.

Manufacturer Narrative

Engineering evaluation completed.The device evaluation showed the following: the leading end of the device had been pulled out of the trailing olive.The leading olive tip was damaged.The findings from the evaluation are consistent with the physician's observations.The root cause for the broken leading end of the catheter could not be determined with the currently available information.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states: do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter separation and reintervention.

Manufacturer Narrative

Added the date of the device returned to the manufacturer.

• 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: kanae rikimaru ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4026524
• MDR Text Key: 4725252
• Report Number: 3007284313-2014-00071
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 10/06/2014

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: 02/28/2017
• Device Catalogue Number: PLC201200J
• Device Lot Number: 12448618
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/11/2014; 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2014
• 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: 81 YR