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

Model Number	PXT231414
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The following was reported to gore: on (b)(6) 2011, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On an unknown date, a follow-up imaging identified a proximal type i endoleak and the aneurysm enlargement (amount unknown).It was reported that the cause of the endoleak was aneurysmal dilatation of the proximal neck.On (b)(6) 2021, a re-intervention was performed to treat the proximal type i endoleak whereas an additional stent graft was implanted for proximal extension.The patient tolerated the procedure.
Additional Manufacturer Narrative
Revised h6.
Additional Manufacturer Narrative
Add device 22595041/04993024009578 to report.
Additional Manufacturer Narrative
An ischemic event was identified during the type i reintervention on (b)(6) 2021 and has been captured in smartsolve case # (b)(4).The ischemia was determined to be an outcome of the procedure, and device 22595041/04993024009578 was added to this case as an additional device involved.The potential involvement of this device has been reported on the mdr previously submitted.This report is to clarify the reason the device was added in the previous submission.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11724466
• Report Number: 2017233-2021-01901
• Device Sequence Number: 3437893
• Product Code: MIH
• UDI-Device Identifier: 00733132610143
• UDI-Public: 00733132610143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: PXT231414
• Device Catalogue Number: PXT231414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 08/03/2021; 08/03/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 08/10/2021; 02/21/2022; 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male