GORE® EXCLUDER® Conformable AAA Endoprosthesis
Received Jul 31, 2026 · Event occurred Jun 18, 2026
Report 3007284313-2026-04971 · MDR key 50095646
Device
Generic name
System, Endovascular Graft, Aortic Aneurysm Treatment
Manufacturer
W. L. Gore & Associates, Inc.Catalog number
CXT261412
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
The following information was reported to Gore:On (b)(6) 2026, the patient underwent an emergency endovascular treatment for a ruptured abdominal aortic aneurysm using GORE® EXCLUDER® Conformable AAA Endoprosthesis and GORE® EXCLUDER®AAA Endoprosthesis devices. On (b)(6) 2026, follow-up CT imaging suggested the presence of a proximal Type I endoleak. On (b)(6) 2026, a reintervention was performed. Although no definite endoleak was identified on intraoperative angiography, an Aortic Extender component was prophylactically deployed at the proximal end, and the procedure was completed.
Additional Manufacturer Narrative
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.