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

Model Number	PLL161007
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Renal Failure (2041)
Date of Event	05/06/2022
Type of Reportable Event	Death
Event or Problem Description
The following was reported to gore: on may 6, 2022, the patient presented with a right common iliac aneurysm and underwent treatment utilizing two gore® excluder® iliac branch endoprostheses (ibe) and a gore® excluder® aaa endoprosthesis (aaa).Initial imaging revealed a large aneurysm, approximately 4cm x 5cm, and the physician noted a large left accessory renal supplying the lower half of the left kidney approximately 56 milimeters above the aortic bifurcation.The physician elected to utilize the first ibe device and placed it above the aortic bifurcation but below the left accessory renal.The physician then placed an ibe extender device to exclude a right common iliac aneurysm, the ibe device extended into the right external iliac artery.On the contralateral side, the physician utilized the second ibe device, this was implanted without issue.The right hypogastric was then coiled with two cook nester coils (6mm x 14cm) and the procedure was completed.The patient tolerated the procedure.Final imaging confirmed exclusion of the right common iliac aneurysm and flow was observed on the left side and was confirmed by the physician.Approximately 5 hours post-op, the patient presented with acidosis and noted belly pain, mottling was observed over the lower pelvic area and thighs.At approximately 12 hours post-op, the patient went into acute renal failure and ultimately expired.The physician stated the patient's left hypogastric was confirmed to be open during final imaging and the suspected cause of death is mesenteric ischemia.Further information has been requested but has not been made available at this time.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14594041
• Report Number: 3013164176-2022-01395
• Device Sequence Number: 5517233
• Product Code: MIH
• UDI-Device Identifier: 00733132618811
• UDI-Public: 00733132618811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

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: 02/21/2025
• Device Model Number: PLL161007
• Device Catalogue Number: PLL161007
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 05/06/2022; 10/06/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/21/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention; Death
• Patient Age: 68 YR
• Patient Sex: Male