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	12/28/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc121400/ 21543866 udi (b)(4), plc141200/ 22325548 udi (b)(4), pll161407/ 21435624 udi (b)(4), plc121200/ 21057359 udi (b)(4), and plc141400/ 22511899 udi (b)(4).
Event or Problem Description
On (b)(6) 2020, the patient was implanted with a gore® excluder® aaa endoprostheses to treat a ruptured abdominal aortic aneurysm.It was reported there was an unresolved proximal type i endoleak.The physician chose to explant the gore® excluder® aaa endoprostheses and convert to open repair.The patient tolerated the procedure.Reportedly, during procedure, there was a time when chest compressions were performed.The patient had previous heart stents implanted.Later that day on (b)(6) 2020, the patient expired.The cause of death is unknown.
Additional Manufacturer Narrative
Addition: the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Addition: 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.

• 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: 11217689
• Report Number: 3007284313-2021-01233
• Device Sequence Number: 17148322
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 06/15/2023
• Device Model Number: RLT281416
• Device Catalogue Number: RLT281416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 05/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 64 YR
• Patient Weight: 113