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

Catalog Number RLT311413J

Device Problem Positioning Problem (3009)

Patient Problem Occlusion (1984)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment using gore® excluder® aaa endoprostheses for an abdominal aortic aneurysm.It was reported that it was difficult to cannulate into the ipsilateral leg of the trunk - ipsilateral leg endoprosthesis, and it was suspected that the device moved proximally during the cannulation.After all stent grafts were deployed, angiography showed the left renal artery was unintentionally covered.Reportedly, a pta balloon was dilated in the left renal artery, and it seemed that the balloon did not interfere with the device.No delay of flow into the left renal artery was observed by angiography.No additional procedure was performed.A type ii endoleak was observed and it was decided the endoleak will be monitored.The patient tolerated the procedure.

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: 11172885
• MDR Text Key: 227012670
• Report Number: 3007284313-2021-01229
• 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: 02/24/2021

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: 09/05/2021
• Device Catalogue Number: RLT311413J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR