Last fall, FDA circulated findings that rates of a particular type of adverse event were higher than expected for endovascular graft systems intended to repair abdominal aortic aneurysms (AAA). Now the agency says the problem appears to be linked only to one specific device that was previously removed from the market.
Endovascular aneurysm repair (EVAR) devices are intended to exclude the AAA sac from the arterial circulation and prevent the aneurysm from rupturing. But in some instances, a device can cause...