Thoracic endovascular graft recall deemed serious

The FDA has designated a recall of a thoracic endovascular graft as Class I, the most serious kind.

Cook Medical Inc. issued a recall of the graft (Zenith Alpha Thoracic Endovascular Graft), used for the treatment of blunt traumatic aortic injury, in March due to risk for in-device thrombus after implantation, according to a safety alert issued by the FDA.

The company has also received reports of graft occlusion when the device was used for the treatment of blunt traumatic aortic injury, according to the alert.

An updated correction and removal notification issued by the company in June informed customers that treatment of blunt traumatic aortic injury is no longer an indication for the device.

The recall affects all lots manufactured between April 10, 2015 and January 3, 2017 and distributed between October 29, 2015 and March 10, 2017. According to the alert, 4,500 devices will be relabeled and 500 18-mm to 22-mm devices, which would likely be used only for treatment of blunt traumatic aortic injury, will be removed from the market.

According to Cook Medical, patients already treated with the graft for blunt traumatic aortic injury should be followed according the current instructions for use and with considerations outlined in the company’s initial correction and removal notice issued in March.

The FDA stated that healthcare professionals and patients should report adverse events or side effects related to the use of the graft to its MedWatch program at www.fda.gov/MedWatch/report.