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

Model Number	RMT281216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.This event also includes device (b)(4).
Event or Problem Description
The following information was reported to gore through (b)(6): on (b)(6) 2014 the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The maximum diameter of the aneurysm measured 56 mm.The patient's infrarenal neck angle measured 10 degrees.The patient tolerated the procedure.On (b)(6) 2021, angiography was performed, and as a result, the physician performed a transcaval coil embolization and implanted an additional aortic endograft.Patient tolerated the procedure.
Additional Manufacturer Narrative
G1: corrected manufacturing site name and address.H6: added component code 515.
Additional Manufacturer Narrative
H6: code 4580 changed to 4581 following additional information from study center.Type ia and type ii endoleaks were reported.Code 4581 is used to capture endoleak.

• 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: 12780050
• Report Number: 2953161-2021-01102
• Device Sequence Number: 6119673
• Product Code: MIH
• UDI-Device Identifier: 00733132610686
• UDI-Public: 00733132610686
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2022

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: 07/31/2016
• Device Model Number: RMT281216
• Device Catalogue Number: RMT281216
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 02/09/2022; 02/09/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/09/2022; 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 67 KG