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

Model Number	RLT231414
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Ruptured Aneurysm (4436)
Date of Event	10/28/2022
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2022, the patient underwent endovascular procedure using a gore excluder® aaa endoprosthesis featuring c3 delivery system to treat an abdominal aortic aneurysm.Reportedly, during the procedure, the physician experienced some difficulties to do a cannulation.During the cannulation, the patient became unstable and subsequently died.The case was discussed with the physician.The physician is not interested in a device investigation, and believes the death is attributed to the patients pathology/ disease and not due to the device.The cause of death was ruptured aneurysm.No more information is going to be provided by the patient's family wish.
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for investigation.Additional information was requested but is not available based on the patient's family wish.The cause of death was ruptured aneurysm.It is unknown what caused difficulties to do a cannulation and the aneurysm rupture.According to the gore excluder® aaa endoprosthesis featuring c3 delivery system instructions for use (ifu), adverse events that may occur and /or require intervention or additional intraoperative procedure time include, but are not limited to aneurysm rupture and death.Additional considerations for patient selection include but are not limited to: the risk of aneurysm rupture compared to the risk of treatment with the gore® excluder® aaa endoprosthesis and patient¿s anatomical suitability for endovascular repair.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15740142
• Report Number: 3007284313-2022-02195
• Device Sequence Number: 14170337
• Product Code: MIH
• UDI-Device Identifier: 00733132622375
• UDI-Public: 00733132622375
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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: 07/16/2025
• Device Model Number: RLT231414
• Device Catalogue Number: RLT231414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2022
• Initial Report FDA Received Date: 11/04/2022
• Date Device Manufactured: 07/18/2022
• 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: Death; Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Female