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

Catalog Number	CXT201212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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.
Event or Problem Description
The following was reported to gore: on (b)(6) 2022, the patient underwent an endovascular procedure to treat an abdominal aortic aneurysm (aaa) utilizing gore® excluder® conformable aaa endoprosthesis (trunk ipsilateral leg conformable) and gore® excluder® aaa endoprosthesis (contralateral leg and iliac extender).On (b)(6) 2024, patient presented for a yearly follow up after the initial procedure where patient underwent an abdominal ultrasound that showed the aaa had increased in size to 4.6 x 4.1cm from 4.3 x 3.8cm in 2023 (date unknown).The patient is reportedly doing well with no reported complaints of abdominal or back pain and no claudication.On (b)(6) 2025, the patient underwent an endovascular reintervention procedure to treat an expanding aneurysm (55mm) utilizing a gore® excluder® conformable aaa endoprosthesis (aortic conformable extender).Reportedly, due to the patient's expanding aneurysm (cause is unknown) with no clear evidence of endoleak, physician decided to do an elective procedure as a precaution by extending proximally with an aortic conformable extender from the trunk ipsilateral leg conformable.Patient tolerated the procedure.1001-e: -unknown is used to capture cause of the aneurysm enlargement.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22992644
• Report Number: 3007284313-2025-04234
• Device Sequence Number: 9469337
• Product Code: MIH
• UDI-Device Identifier: 00733132650989
• UDI-Public: (01)00733132650989(17)231117
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 11/17/2023
• Device Catalogue Number: CXT201212
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 76 KG