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

Catalog Number	CXT361414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2025, the patient underwent emergency endovascular treatment for a ruptured abdominal aortic aneurysm using the gore® excluder® conformable aaa endoprosthesis.Although no endoleak was observed, a proximal extension was planned to prevent potential future occurrence of a type i endoleak.On (b)(6), 2025, the patient underwent reintervention to reinforce proximal sealing.An additional stent graft was deployed at the proximal end of the previously placed device.Physician¿s comment: no endoleak was observed, but the extension was performed to secure a longer sealing zone.
Additional 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 have not 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.
Additional Manufacturer Narrative
H6: code d12: h6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2025, the patient underwent emergency endovascular treatment for a ruptured abdominal aortic aneurysm using the gore® excluder® conformable aaa endoprosthesis.On an unknown date in (b)(6) 2025, although no endoleak was observed, a proximal extension was determined to prevent potential future occurrence of a type i endoleak.On (b)(6) 2025, the patient underwent reintervention to reinforce proximal sealing.An additional stent graft (medtronic, endurant ii) was deployed at the proximal end of the previously placed device.Physician¿s comment: no endoleak was observed, but the extension was performed to secure a longer sealing zone.1000-e: -other - explained in file: a proximal extension was determined to prevent potential future occurrence of a type i endoleak.
Additional Manufacturer Narrative
B3/b4/b5/b6: describe event or problem has been updated.

• 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: ayako yoshioka ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22379870
• Report Number: 3007284313-2025-04066
• Device Sequence Number: 9355008
• Product Code: MIH
• UDI-Device Identifier: 00733132651078
• UDI-Public: (01)00733132651078(17)271003
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2025

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 Catalogue Number: CXT361414
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 06/24/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/30/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female