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

Catalog Number RLT351418J

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem Occlusion (1984)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

According to the gore(r) excluder(r) aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoprosthesis improper component placement.

Event Description

The following information was reported to gore: on (b)(6) 2021, the patient underwent endovascular treatment for an abdominal aortic aneurysm using gore(r) excluder(r) aaa endoprostheses.The patient's aortic neck was described to be angular.The device was deployed slightly above the right renal artery with the intention to subsequently bring down and reposition the device below both renal arteries.However, the device could not be repositioned and both renal arteries were covered by the device.The physician attempted to move the device down by constraining the device, but it was reported that the device became attached to the narrowed inner curvature of the aortic wall and could not be repositioned.Stents were placed in both renal arteries.Blood flow to both renal arteries was confirmed.A proximal type i endoleak was also discovered.It was decided the patient will be monitored and the procedure was completed.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the 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, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11215162
• MDR Text Key: 228211123
• Report Number: 3007284313-2021-01232
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2023
• Device Catalogue Number: RLT351418J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR