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 Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/14/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.¿per ifu, users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
On (b)(6) 2009, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.A type ii endoleak was reportedly observed on a final procedural angiograph.The physician elected to monitor endoleak, and the procedure was completed.The patient tolerated the procedure.On an unknown date, a follow-up examination reportedly showed aneurysm enlargement (amount unknown) due to a type ii endoleak originating from the inferior mesenteric artery.On (b)(6) 2021, coil embolization was performed to treat the type ii endoleak.The patient tolerated the procedure.

• 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13002428
• Report Number: 2017233-2021-02610
• Device Sequence Number: 11841532
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2012
• 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): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/14/2021
• Date Device Manufactured: 07/07/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male