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

Model Number	RLT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/30/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: rlt281414/ 20576879 udi (b)(4), plc181000/ 21577937 udi (b)(4), and pla280300/ 21636920 udi (b)(4).Code 213-the review of the manufacturing paperwork verified that these lot/serial numbers met all pre-release specifications.Code 22-according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), the following warning among others: adverse events that may occur and/or require intervention include, but are not limited to: endoleak and death.
Event or Problem Description
On an unknown date the patient was implanted with a tube graft to treat an abdominal aortic aneurysm.It was reported that on (b)(6) 2020, the patient presented with a ruptured iliac aneurysm.The physician had planned to intervene and coil the hypogastric artery and then implant gore® excluder® aaa endoprosthesis to contain the ruptured aneurysm.There were multiple issues while attempting to advance the guidewires.The physician then attempted an aui.The aui was successful and the gore® excluder® aaa endoprostheses were implanted.However, a proximal type i endoleak was present.The physician wanted to take a wait and approach on endoleak.The patient tolerated the procedure.Later that day on (b)(6) 2020, the patient expired.No further information is available on the cause of death.
Additional Manufacturer Narrative
Added the pma/510(k) number to g3/g4: p020004.

• 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: 11083485
• Report Number: 3007284313-2020-01208
• Device Sequence Number: 14472720
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 08/27/2023
• Device Model Number: RLT281416
• Device Catalogue Number: RLT281416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 09/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 71 YR