Cook Medical this month released an urgent safety notice warning of clot risks associated with its Zenith Alpha thoracic endovascular graft when used to treat blunt thoracic aortic injuries.
The company warned of a 25% observed rate of thrombus within the graft during follow-ups to a clinical trial evaluating the use of the device for treating BTAI, though none of the cases required an open surgical conversion or bypass. In past studies, the rate of thrombus within grafts ranges from 15% to 40%, the company said.
Cook Medical said it has received 5 reports of graft thrombosis or occlusion during global commercial use of the device, each following treatment for BTAI. One such case resulted in a patient’s death, while 3 other cases required reinterventions.
Patients who experienced thrombus formation after interventions with the device had smaller graft diameters and greater oversizing on average than patients without reported thrombus, Cook said in its urgent field safety notice.
The company clarified that no devices are required to be returned with the notice, but that patients already treated with the device for blunt thoracic aortic injuries should continue with their follow-ups.
Cook Medical reinforced the importance of “careful patient selection and device planning and sizing” in relation to the issue, and reinforced the importance of life-long regular follow-ups to assess endovascular graft performance.