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

Catalog Number PLC201000J

Device Problems Break (1069); Physical Resistance (2578)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is being returned to gore but has yet been received.

Event Description

On (b)(6) 2018, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.When attempting to advance the delivery catheter of the contralateral leg component over the guidewire, it was reported that the delivery catheter got stuck on the guidewire and resistance was encountered.An attempt was made to remove the catheter off the guidewire, but was not successful.Additional force was exerted and the delivery catheter was able to be removed from the guidewire, but the delivery catheter was broken in the process.The device was set aside and another device was used to conclude the procedure.The patient tolerated the procedure without further issue.

Manufacturer Narrative

D10/h3: device is not being returned to gore, no further analysis will be provided.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7465420
• MDR Text Key: 107193071
• Report Number: 3013164176-2018-00032
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/06/2018

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: 12/14/2020
• Device Catalogue Number: PLC201000J
• Device Lot Number: 17562099
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1