GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Description of Event or Problem

The following publication was reviewed: Title: Surgical Strategies for Descending and Thoracoabdominal Aortic Surgery after TEVAR and the Significance of the Adamkiewicz Artery.Source: The 55th Annual Meeting of the Japanese Society for Cardiovascular Surgery, Abstracts, Page MO35-2, 2025This study evaluated five patients who underwent descending or thoracoabdominal aortic surgery after prior thoracic endovascular aortic repair (TEVAR) between 2018 and 2023. The assessment focused on proximal anastomotic techniques, identification and reconstruction of the Adamkiewicz artery (AKA), and the occurrence of spinal cord injury.The patient characteristics included a mean age of 68 ± 6 years, and four patients were male. The indications for the initial TEVAR were true aneurysm in four patients and dissecting aneurysm in one patient. The devices used for the initial TEVAR were Gore TAG in one patient, Valiant in two patients, Relay in one patient, and a handmade device in one patient.The mean interval from the initial TEVAR to reintervention was 68 ± 46 months. The indication for reintervention was aneurysm enlargement in all five patients. The causes of aneurysm enlargement were Endo leak in four patients, including Type Ia + Ib in one, Type Ib in one, Type II in one, and Type IIIb in two, and false lumen enlargement due to re-entry in one case.All procedures were performed through a left thoracotomy with preservation of the latissimus dorsi muscle. The surgical procedures consisted of descending aortic replacement in two patients, thoracoabdominal aortic replacement in two patients, and aneurysmorrhaphy in one patient. The previously implanted TEVAR device was removed in two patients, partially preserved in two patients, and fully preserved in one patient.The Adamkiewicz artery was identified in four patients. In two patients, the AKA had been occluded by the prior TEVAR. In one patient, the AKA was located outside the replacement range. In one patient, the AKA was located within the replacement range and was reconstructed.Among the two patients in whom segmental arteries had been occluded by TEVAR, one developed transient paraplegia, which improved with blood pressure augmentation and cerebrospinal fluid drainage. In the other patient, intraoperative hypotension was associated with a decrease in motor evoked potentials; however, the motor evoked potentials improved after hemodynamic stabilization, and no spinal cord injury occurred. No spinal cord injury was observed in patients in whom the AKA was preserved or reconstructed.

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 could not be performed as a valid lot number was not provided. Literature title: Surgical Strategies for Descending and Thoracoabdominal Aortic Surgery after TEVAR and the Significance of the Adamkiewicz ArterySource: The 55th Annual Meeting of the Japanese Society for Cardiovascular Surgery, Abstracts, Page MO35-2, 2025.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.