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

Model Number	RMT231414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional 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 endoleaks.Additionally, users are made aware of the risks associated with type ii endoleaks ¿in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2012 a patient underwent treatment of an abdominal aortic aneurysm in the grt10-11 study with gore¿ excluder¿ aaa endoprostheses.On (b)(6) 2021 the patient exhibited a type ii endoleak which was treated by means of biological glue.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.
Additional Manufacturer Narrative
B1: corrected adverse event entry.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12144112
• Report Number: 3007284313-2021-01499
• Device Sequence Number: 3989099
• Product Code: MIH
• UDI-Device Identifier: 00733132610556
• UDI-Public: 00733132610556
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2022

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: 01/31/2015
• Device Model Number: RMT231414
• Device Catalogue Number: RMT231414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 03/15/2022
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/28/2021; 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 80