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

Catalog Number CXA360005

Device Problem Human-Device Interface Problem (2949)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/09/2023

Event Type  malfunction  

Event Description

The field sales associate (fsa) reported the following: on (b)(6) 2023, the patient underwent endovascular treatment of a pseudoaneurysm in the ascending aorta using gore® excluder® conformable aaa endoprostheses.It was reported as the fellow physician was deploying the gore® excluder® conformable aaa endoprostheses (aortic extender), she paused (looked up at the screen in order to identify placement location) midway through the deployment pull.The device did deploy and ¿had the appearance of being at a angle and folding back on itself¿.¿the aortic extender appeared to tumble at the distal end of the device and sat at an angle in the aorta.¿ a additional gore® excluder® conformable aaa endoprostheses (aortic extender) was then deployed/implanted successfully.The patient tolerated the procedure.The fsa reported that there was an obvious pause during the deployment.The fellow made a claim that the deployment mechanism was "stuck" and that caused the pause in deployment.However, the fsa witnessed the fellow pause to look up at the screen to identify placement location of the aortic extender and that was what instituted the "pause" in deployment.

Manufacturer Narrative

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.

Manufacturer Narrative

Addition: gore engineering performed a engineering evaluation, no device was returned.Per the evaluation, the reported failure mode of the device moving during deployment could not be independently confirmed.No images, nor the physical device were available to allow for evaluation of the reported failure mode.As reported, there was a pause as the deployment knob was pulled, however per the instructions for use deployment should be performed using a steady and continuous pull of deployment knob.A pause in deployment may have contributed to the device deploying at an angle, but there is no way to confirm this had occurred.Additionally, the root cause of the pause in deployment could not be established with the available information.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18387768
• MDR Text Key: 331497084
• Report Number: 3007284313-2023-02978
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132650972
• UDI-Public: 00733132650972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CXA360005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/09/2023
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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): Hospitalization
• Patient Age: 18 YR
• Patient Sex: Male