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

Catalog Number	CXT281412
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore on august 18, 2025, from the medidata study database and change email: on (b)(6) 2025, this 65-year-old male patient underwent endovascular treatment for an abdominal aortic aneurysm (no iliac involvement).The patient was treated with a gore® excluder® conformable aaa endoprosthesis trunk ¿ ipsilateral leg device, two gore® excluder® aaa contralateral leg endoprosthesis devices in the right external iliac artery, and a gore® excluder® aaa contralateral leg endoprosthesis device in the left external iliac artery.The sites were accessed percutaneously on the left and right.The gore® devices were successfully navigated to the intended locations and successfully deployed.Device catheters were successfully removed after successful access, delivery and deployment of the devices.There were no access-related complications.The patient also had embolization of the internal iliac artery with coils.The patient was discharged home on (b)(6) 2025.On (b)(6) 2025, the patient had an endoleak type ii.This adverse event required hospitalization and treatment with a reintervention.On (b)(6) 2025, the patient underwent embolization with coils.This adverse event is noted as recovered/resolved without sequelae on (b)(6) 2025.
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.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® 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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22935684
• Report Number: 3007284313-2025-04226
• Device Sequence Number: 9755184
• Product Code: MIH
• UDI-Device Identifier: 00733132651054
• UDI-Public: (01)00733132651054(17)270813
• 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,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: CXT281412
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 62 KG