The FDA has issued an alert to health care providers and patients concerning its Amplatzer Atrial Septal Occluder (ASO). It seems that in very rare instances, tissue surrounding the device can erode, resulting in life-threatening emergencies that require immediate surgery.
The St. Jude Amplatzer Atrial Septal Occluder is a cardiac implant device used in children and adults to treat atrial septal defects (ASD). The device, which comprises a double disc of metallic mesh and polyester fabric, is put into place through a catheter inserted into a vein, a minimally invasive method for ASD closure, and an alternative to open heart surgery.
Over time it seems sometimes implanted devices can rub against the wall of the heart and erode the tissue, creating a hole. The FDA alert says it can also lead to further scraping or erosion through tissue in the 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 pericardial sac surrounding the heart. If too much blood builds up in this sac, the heart will suffer cardiac tamponade and may not be able to work properly.
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. According to published estimates, these events occur in approximately 1 to 3 of every 1,000 patients implanted with the Amplatzer ASO. As of March 31, 2013, there have been 234,103 Amplatzer ASO devices sold worldwide.
To better understand how erosion impacts the performance of the Amplatzer ASO and assess potential risk factors related to the occurrence of erosion, the FDA is requiring St. Jude to conduct a study of patients who have been recently implanted with the device. 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.
Healthcare professionals have been directed to review the updated Instructions For Use (IFU) for the Amplatzer ASO before implanting the device. Recommendations say they should consider the potential for erosion when talking to patients about long- and short-term benefits and risks of treatment options, including implantation with the Amplatzer ASO. They should also educate patients implanted with the device to seek immediate medical attention if they develop symptoms such as chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat.
The FDA stops short of recommending device removal unless physicians determine it is appropriate for their particular patient(s). The risks associated with device removal surgery may be equal to or greater than the risk of erosion.
Find the FDA’s warning letter here.