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

Catalog Number RLT261414J

Device Problem Malposition of Device (2616)

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

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications; according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, improper component placement.

Event Description

On (b)(6) 2020, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprostheses.Trunk ipsilateral leg endoprosthesis was deployed just below the lowest left renal artery.The device was deployed while pushing up, resulting in the entire device moving proximally and unintentionally coverage of the left renal artery.The physician attempted to correct the device position by using a balloon, but it was not successful.No delay was detected in blood flow into the left renal artery.It was also reported type ii endoleak from the lumbar artery.It was decided the patient will be monitored and the procedure was completed.

Manufacturer Narrative

Added pma/510(k) number.

• 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: 11141215
• MDR Text Key: 225827276
• Report Number: 3007284313-2021-01223
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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: 05/18/2023
• Device Catalogue Number: RLT261414J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 05/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR