MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® EXCLUDER® Conformable AAA Endoprosthesis; System, Endovascular Graft, Aortic Aneurysm Treatment

Catalog Number	CXT231412
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following publication was reviewed: title: treatment of patients with severely angulated proximal aortic necks using the gore excluder conformable aaa endoprosthesis.Source: the 56th annual meeting of the japanese society for cardiovascular surgery, o61-6.It was reported the outcomes of four patients with severely angulated proximal aortic necks of 90 degrees or greater who underwent endovascular aneurysm repair at the one institution between april 2023 and july 2025.The gore excluder conformable aaa endoprosthesis was used in all patients.¿case 2¿ a 75-year-old man with a medical history of cerebral infarction, myocardial infarction treated with percutaneous coronary intervention, rectal cancer surgery, and emphysema.The patient underwent evar because the abdominal aortic aneurysm measured more than 50 mm in diameter and showed progressive enlargement.The proximal aortic neck angle was 97 degrees, and the neck length was 25 mm.The main device was angulated to conform to the infrarenal aortic angulation and was subsequently deployed.Intraoperative angiography showed no abnormal findings.A type ii endoleak was identified postoperatively.Transcatheter arterial embolization was performed 21 months after the procedure.
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Literature title: treatment of patients with severely angulated proximal aortic necks using the gore excluder conformable aaa endoprosthesis source: the 56th annual meeting of the japanese society for cardiovascular surgery, o61-6.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: rie kaba ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50911106
• Report Number: 3007284313-2026-05105
• Device Sequence Number: 12111040
• Product Code: MIH
• UDI-Device Identifier: 00733132651016
• UDI-Public: (01)00733132651016(17)260121
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 01/21/2026
• Device Catalogue Number: CXT231412
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2023
• 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 Age: 75 YR
• Patient Sex: Male