Patients treated with a Medtronic AneuRx stent to prevent aneurysms appear more likely to die than those who undergo surgery, the FDA said Tuesday. The FDA said new data on the company's AneuRx stent showed patients who've had the device implanted for five years are increasingly likely to die of an aneurysm. FDA has issued similar alerts before, but the new data show the risks keep climbing years after the stent is implanted.

The small, mesh-wire tube is inserted into the abdominal aorta, a vessel that provides blood to the lower body. The stent is designed to prevent bulging of the aorta, which can burst and cause sudden death. Medtronic said about 1.2 million people in the U.S. are at risk of the aneurysms, though only half are ever treated. About 75,000 patients in the U.S. have its stent, which is an alternative to surgery.

FDA estimated that 1.5 percent of patients who've had AneuRx five years will die from an aneurysm, well above the 0.18 percent death rate in patients who had surgery. FDA estimated that 1.5 percent of patients who've had AneuRx five years will die from an aneurysm, well above the 0.18 percent death rate in patients who had surgery.

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