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

Catalog Number	CXT321414
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported from the tgr23-02aa together aortic registry: on (b)(6) 2024, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis (excc) trunk-ipsilateral leg component in the infrarenal abdominal aorta.The maximum diameter of the abdominal aorta was 96mm.The device was successfully navigated to the intended location and successfully deployed.The patient tolerated the procedure.The patient was discharged to home on (b)(6) 2024.On (b)(6) 2024, a type ii endoleak was observed, embolized, and was noted to be resolved.On the same date, the type ii endoleak was observed again.On (b)(6) 2024, coil embolization of multiple iliolumbar branches and the inferior mesenteric artery was performed to treat the type ii endoleak.The adverse event was noted as resolved on (b)(6) 2024.
Additional Manufacturer Narrative
D.10.Concomitant medical products and therapy dates: hypercholesterolemia medication (not specified), hypertension medication (not specified).H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® excluder® conformable aaa endoprosthesis instructions for use, potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak.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.
Additional Manufacturer Narrative
B.5.Event description: updated description added.H.6.Investigation conclusions: code d12 updated to code d14.As additional information was received that the endoleak was ongoing and not a new endoleak, the ongoing endoleak and endoleak treatments have been captured under manufacturer report #3007284313-2025-03979 and this report will be retracted as a duplicate.
Event or Problem Description
On (b)(6) 2024, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis (excc) trunk-ipsilateral leg component in the infrarenal abdominal aorta.The maximum diameter of the abdominal aorta was 96mm.The device was successfully navigated to the intended location and successfully deployed.The patient tolerated the procedure.The patient was discharged to home on (b)(6) 2024.On (b)(6) 2024, a type ii endoleak was observed.On (b)(6) 2024, an embolization was performed to treat the type ii endoleak.The endoleak was noted as ongoing.On (b)(6) 2024, coil embolization of multiple iliolumbar branches and the inferior mesenteric artery was performed to treat the type ii endoleak.The adverse event was noted as resolved on december 6, 2024.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22040660
• Report Number: 3007284313-2025-03980
• Device Sequence Number: 21106023
• Product Code: MIH
• UDI-Device Identifier: 00733132651061
• UDI-Public: (01)00733132651061(17)270730
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: CXT321414
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 FOR LIST OF MEDICATIONS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White