WASHINGTON, DC — The US Food and Drug Administration has alerted providers and patients that the catheter-delivered Amplatzer atrial septal occluder (ASO) from St Jude Medical poses a small risk of potentially life-threatening complications. Over time, the device can erode the surrounding tissue and may cause cardiac tamponade or other problems that require immediate surgery, according to the agency.
It estimates the risk of such emergencies at one to three per 1000 implanted patients and notes that >230 000 Amplatzer ASO devices have been sold around the world.
The agency "does not recommend device removal" for patients implanted with the Amplatzer ASO, unless physicians determine on a case-by-case basis that removal is appropriate.
"Between 2002 and 2011, the FDA received more than 100 reports of erosions associated with the St Jude Amplatzer ASO. During the same period, several medical journals contained articles reporting tissue erosion among patients implanted with this device," the agency notes. The device has been available in the US since 2001.
There has been plenty of public discussion about the problem, including a May 2012 meeting of the agency's Circulatory System Devices Advisory Committee that explored a range of complications associated with the device. It expressed particular bafflement about the potential for erosions. As covered by heartwire , the panel recommended that the problems be studied further in a retrospective case-control study, a prospective registry, or both.
"The FDA is requiring St Jude to conduct a study of patients who have been recently implanted with the device" to learn about potential risk factors for erosion and how erosions affect the implant's performance, the agency said in its latest statement. "The study is designed to estimate the incidence of erosion events within seven days, one month, six months, and 12 months after the implantation of the Amplatzer ASO."
Cite this: FDA Issues Amplatzer ASO Occluder Safety Alert Over Erosions - Medscape - Oct 18, 2013.