Early Adverse Events Following the Deployment of Cook Zenith Stent-Grafts in the Descending Thoracic Aorta: Examination of the Explanted Devices
摘要
Thoracic endovascular aortic repair (TEVAR) created a new strategy to treat descending thoracic aneurysms and was progressively extended to traumatic aortic transections, type B dissections, penetrating aortic ulcers, and thoracoabdominal aneurysms. The mismatch between devices and patients’ requirements deserves investigation of the adverse events. We hereby report on three patients: two necessitated conversions and one fatality. The first patient was treated after a roll-over motor vehicle collision causing a tear in the descending thoracic aorta. The second patient presented long-standing thoracoabdominal aneurysms. Further to a suspected rapture, the endovascular procedure was undertaken and the patient passed away after 2 days. The third patient was diagnosed with type B aortic dissection. Two months after the endovascular treatment, the diameter of the aneurysms increased distally. The zigzag shaped stents do not allow adequate flexibility to the conduits to adapt the curvature of the thoracic aorta. The design of hooks was less than optimal due to a questionable technique of welding. The woven fabric could not behave as a scaffold. These three adverse events could at first be considered patient related. However, these prostheses might not be optimally designed. Several issues hereby raised are being addressed, and ongoing validations are in progress.