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

Catalog Number PLC201400

Device Problems Detachment Of Device Component (1104); Unintended Collision (1429); Difficult to Remove (1528)

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

Event Date 02/19/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, the patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.Reportedly, the contralateral leg component was deployed without issue.It was reported that during withdrawal of the delivery catheter back into the sheath, the device caught on the edge of the sheath, causing the leading olive to completely separate from the graft and remain within the patient.The physician was able to snare the olive for removal from the patient.The procedure was concluded with no further issue, and the patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

The catheter was returned for evaluation.The evaluation showed that the leading end of the catheter had separated from the catheter body at the trailing olive.The guidewire lumen had pulled out of the trailing olive bond on the catheter.The findings from the evaluation are consistent with the physician¿s observations.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), 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.The catheter separation was due to the polyimide guidewire lumen pulling out of the trailing olive.The root cause for the broken leading end of the catheter could not be determined with the currently available information.

Manufacturer Narrative

(b)(4).

• 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: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4614184
• MDR Text Key: 5592899
• Report Number: 3007284313-2015-00028
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: PLC201400
• Device Lot Number: 13301962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2015
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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: 86 YR
• Patient Weight: 75