The FDA is warning physicians that heart tissue surrounding the St. Jude Medical Amplatzer atrial septal occluder can erode. That can lead to life-threatening emergencies that require immediate surgery, according to the FDA.
In a safety communication, the FDA reported that the atrial septal occluder can create a hole in tissue if it rubs against the heart wall.
“It can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. This scraping may also cause separate or simultaneous holes in the aortic root, potentially leading to blood building up in the sac surrounding the heart (cardiac tamponade),” the FDA wrote, which can impair heart function.
The agency characterized the occurrence as very rare, adding that one to three of every 1,000 patients may be affected.
In the period between 2002 and 2011, it received more than 100 reports of erosions associated with the Amplatzer device. At the FDA’s request, St. Jude will conduct a study of patients who have been recently implanted with the device to estimate the incidence of erosion events up to a year after implantation. The device was approved in 2001.
The FDA cautioned physicians to not remove the device unless they consider such action appropriate. It wrote that the risks associated with surgery might be equal to or greater than the risk of erosion.
It recommended physicians review device instructions before implantation; inform patients about long- and short-term benefits and risks; and educate them to get immediate medical care if they experience various symptoms.
Adverse events or side effects should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.