GORE® EXCLUDER® Iliac Branch Endoprosthesis

Description of Event or Problem

The following information was reported to Gore:On (b)(6)2024, the patient underwent an endovascular treatment for an abdominal aortic aneurysm and the iliac artery aneurysm using GORE® EXCLUDER® AAA Endoprosthesis and GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE). Non-Gore stent graft (AFX) was used for the main body. IBE was implanted in the right side of the patient.On (b)(6), 2024, an additional stent graft was placed in the left side.On (b)(6) 2026, postoperative CT confirmed that blood flow to the right lower limb was impaired due to the leg placed on the left side. It was reported that there was no device malfunction, such as migration, associated with the left sided leg.On (b)(6)2026, reintervention was performed. Angiography via sheath injection from the right femoral artery confirmed complete occlusion on the right side, distal to PLC231000J and CEB231010A. As treatment, a femoro-femoral bypass was performed, 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.