Health Canada — Medical Devices · Canada · 2017-06-30 · Type I
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Reported risk: William Cook Europe ApS has learned of an issue affecting the Zenith Alpha Thoracic Endovascular Grafts. As described in the recent field safety notice 2017FA0001 of March 2017 regarding the Zenith Alpha Thoracic Endovascular Graft, there were complaints involving thrombosis/occlusion of the product when used to treat blunt thoracic aortic injury (BTAI). Since that time, Cook Medical has received additional complaints for the same problem. Although the complaints were from patients treated prior to issuance of the above noted field safety notice, cook medical is initiating a voluntary correction of the instructions for use (IFU) and is also voluntarily removing specific sizes of the Zenith Alpha Thoracic Endovascular Graft from the market. The manufacturer is voluntarily removing the indication for blunt thoracic aortic injury. The specific sizes of 18-22 mm used for the BTAI indication is being recalled from the market and will no longer be available. The IFU will be corrected for the remaining sizes on the market used for endovascular treatment of patients with isolated lesions of the descending thoracic aorta.
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