Patients treated with a Medtronic stent to prevent aneurysms appear more likely to die than those who undergo surgery, the Food and Drug Administration said Tuesday.
The FDA said new data on the company’s AneuRx stent showed patients with the device were increasingly likely to die of an aneurysm. FDA issued similar alerts in 2001 and 2003, but the agency said the new data shows risks continue rising five years after the device 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 as an alternative to surgery, which is often necessary to treat dangerous bulges of the aorta. However, FDA said in rare cases the device appears to raise the risk of fatal events.
FDA estimated that 1.5 percent of patients who’ve had the device five years will die from an aneurysm, well above the 0.18 percent death rate in patients undergoing surgery.
The agency said the stents’ risks vary greatly depending on the age and health of the patient. For a 70-year-old patient in good health, FDA said the risk of death is only 2 percent, but for someone with multiple health problems, such as heart or lung damage, the risk could be as great as 40 percent.
FDA recommended Tuesday that doctors only use AneuRx according to its labeling. Doctors sometimes use stents off-label, or outside of FDA-approved uses, in other types of blood vessels.
Medtronic did not immediately return calls for comment.
