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

Catalog Number RLT261412J

Device Problem Material Invagination (1336)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore: on (b)(6) 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.No issues were observed during the procedure.On an unknown date, follow-up exam reportedly identified infoldings of the proximal portion of the trunk-ipsilateral leg component and a proximal type i endoleak.On (b)(6) 2021, a sales associate was informed of the event and a plan to perform an additional procedure.On (b)(6) 2021, additional stent grafts were implanted to extend the proximal neck.The infoldings and the endoleak was resolved, and the patient tolerated the procedure.It was reported that the diameter of the proximal neck was 19.4-22.7mm, and that there was a beak at the inner curve of the proximal neck (angle unknown).

Manufacturer Narrative

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, occlusion of device or native vessel and endoleak.

• 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
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: greg rawling ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11635276
• MDR Text Key: 244942660
• Report Number: 3007284313-2021-01374
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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: 09/25/2023
• Device Catalogue Number: RLT261412J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male