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

Catalog Number RLT351414J

Device Problem Migration (4003)

Patient Problems Cardiac Arrest (1762); Ruptured Aneurysm (4436)

Event Date 09/10/2023

Event Type  Death  

Event Description

On (b)(6) 2023, in the evening, this patient underwent an emergency endovascular treatment of aneurysm rupture using gore® excluder® aaa endoprosthesis for abdominal aorta.After deployment of the stent graft, suspected type i endoleak still existed due to the tortuosity of the proximal neck.In order to lower abdominal blood pressure, a laparotomy and blood aspiration were performed.After returning to the room, the patient¿s blood pressure rose rapidly, then suddenly dropped, resulting in cardiac arrest.The patient expired that night.It was suggested that migration of the device may have occurred during blood aspiration.In addition, it was considered possible that the aneurysm rupture was caused by a suspected proximal type i endoleak.Physician commented the following: originally, the patient was brought in such bad condition, the lifesaving could not be achieved.

Manufacturer Narrative

H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.H6: code b20-device remains implanted.It should be noted that, per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoleak, component migration, and death.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
• Type of Device: 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17882271
• MDR Text Key: 325060995
• Report Number: 3007284313-2023-02806
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: RLT351414J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/05/2023
• Date Device Manufactured: 09/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death