Patients using Medtronic Inc.'s AneuRx stent graft system have a higher mortality rate than previously thought, the U.S. Food and Drug Administration announced this week. In a statement posted on its Web site, the FDA wrote that the per-year mortality risk in patients receiving the stent continues to increase for years after the device is implanted. The mortality rate is also significantly higher for patients who have the stent than for patients who have surgery, the FDA said.

Earlier research had suggested that aneurysm-related mortality was approximately 0.4% per year, the statement said, but longer-term data suggested that mortality reaches 1.5% in the fifth year post-implant. "These rates are substantially higher than the mortality rate for open surgical repair, which average 0.18% per year with a range of 0% to 0.3% per year," the FDA said. "In addition, we now calculate ... a mortality rate associated with the initial surgery of 2.3% instead of the 1.5% originally calculated."

Medtronic's AneuRx stent is designed to treat a condition known as abdominal aortic aneurysm, or AAA, a life-threatening condition in which the aortic artery swells and can burst. According to Medtronic, about 75,000 people have the stent. Medtronic spokesman Daniel Beach told the Associated Press that the deaths cited by the FDA were 13 out of 931 patients the agency studied. Many of the patients who died were elderly or got poor follow-up care, he said.

Click here for more information about Medtronic AneuRx dangers and your legal rights.