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

Catalog Number	CXA320005
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, this patient underwent emergent endovascular treatment of an abdominal aortic aneurysm rupture using gore® excluder® aaa endoprosthesis and gore® excluder® conformable aaa endoprosthesis.After a trunk-ipsilateral leg component was deployed, the proximal side of the device migrated and fell into the aneurysm.Three aortic extender components were deployed from distal to the renal artery and the third one bridged to the trunk-ipsilateral leg component.The forth aortic extender component was deployed from more proximally.While ballooning the forth device, the third aortic extender component migrated proximally and separated from the trunk-ipsilateral leg component.The fifth aortic extender component was deployed as it bridge the third aortic extender component and the trunk-ipsilateral leg component, however, the fifth one was migrated proximally.Then the sixth aortic extender component was deployed and successfully bridged to the trunk-ipsilateral leg component.Reportedly, a proximal type i endoleak was observed on the angiography, the procedure was converted to a surgical procedure and a y-graft replacement was performed.The patient tolerated the procedure.It was reported that the proximal neck length was about 1 cm and highly angulated, about 100 degree.
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), 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.

• 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: hiroko sakamiya ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21465501
• Report Number: 3007284313-2025-03786
• Device Sequence Number: 14365673
• Product Code: MIH
• UDI-Device Identifier: 00733132650965
• UDI-Public: (01)00733132650965(17)261109
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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: CXA320005
• 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: 02/03/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male