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

Description of Event or Problem

Akihito Matsushita et al. "A Case of Repeated Redissection and Aortic Rupture After Thoracic Endovascular Aortic Repair for Type B Aortic Dissection" The 55th Annual Meeting of Japanese Society for Cardiovascular Surgery, Page MO28-6(2025.02)A 77-year-old man with a history of endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysm and thoracic endovascular aortic repair (TEVAR) for type B aortic dissection at another institution was referred to our hospital for treatment of an acute type A aortic dissection that developed 9 months after TEVAR. An entry tear was identified in the ascending aorta, unrelated to the previously implanted stent graft, and ascending aortic replacement was performed. Four months after surgery, a new dissection and rupture of the aortic arch were detected, and total arch replacement(TAR) was subsequently undertaken. The postoperative course was complicated by mediastinitis, requiring omental flap transposition. Beginning 4 months after the reintervention, recurrent type B aortic dissections originating from stent graft¿induced new entry at the distal end of the device(dSINE) were observed every 2 months, necessitating additional TEVAR procedures. During the third TEVAR on (b)(6) 2022, the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG) was implanted; however, dSINE occurred again, resulting in aortic rupture. Descending aortic replacement was subsequently performed, but postoperative bleeding persisted, and the patient died on the day following surgery.It was reported that during replacement of the descending aorta for a dSINE that had developed at the distal end of the CTAG device, esophageal perforation and lung perforation occurred intraoperatively, and hemostasis could not be achieved. The physician reported that the critical cause of death was the intraoperative esophageal perforation.

Additional Manufacturer Narrative

Literature title : A Case of Repeated Redissection and Aortic Rupture After Thoracic Endovascular Aortic Repair for Type B Aortic DissectionSource: The 55th Annual Meeting of Japanese Society for Cardiovascular Surgery, Page MO28-6(2025.02).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.