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

Model Number	RLT351418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications; 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, endoleak.
Event or Problem Description
The following information was reported to gore through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2015 the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The maximum diameter of the aneurysm measured 74 mm.The patient's infrarenal neck angle measured 16 degrees.The patient tolerated the procedure.Follow up computed tomography angiography (cta) examination on (b)(6) 2015 showed the aneurysm measured 74 mm.Follow up computed tomography angiography (cta) examination on (b)(6) 2016 showed the aneurysm measured 74 mm.Follow up computed tomography angiography (cta) examination on (b)(6) 2017 showed the aneurysm measured 82mm.Follow up computed tomography angiography (cta) examination on (b)(6) 2017 showed the aneurysm measured 79 mm.Follow up computed tomography angiography (cta) examination on (b)(6) 2018 showed the aneurysm measured 84 mm.Follow up computed tomography angiography (cta) examination on (b)(6) 2018 showed the aneurysm measured 88 mm.Follow up computed tomography angiography (cta) examination on (b)(6) 2018 showed the aneurysm measured 85 mm.Follow up computed tomography angiography (cta) examination on (b)(6) 2019 showed the aneurysm measured 90 mm.Follow up computed tomography angiography (cta) examination on (b)(6) 2020 showed the aneurysm measured 95 mm.On (b)(6) 2020 plug embolization of the celiac artery as well as a celiac and sma arteriogram was performed to treat a type ia 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
• MDR Report Key: 10885154
• Report Number: 3007284313-2020-01163
• Device Sequence Number: 2895258
• Product Code: MIH
• UDI-Device Identifier: 00733132618491
• UDI-Public: 00733132618491
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: 10/31/2017
• Device Model Number: RLT351418
• Device Catalogue Number: RLT351418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 84