FDA Issues Alert Regarding Rare Erosion Events With St. Jude Medical's Amplatzer Atrial Septal Occluder

October 17, 2013—The US Food and Drug Administration issued a safety communication to alert health care providers and patients that in very rare instances, tissue surrounding the Amplatzer atrial septal occluder (ASO; St. Jude Medical, Inc., St. Paul, MN) can break down (erode) and result in life-threatening emergencies that require immediate surgery. According to published estimates, these events occur in approximately 1 to 3 of every 1,000 patients implanted with the Amplatzer ASO. There have been 234,103 Amplatzer ASO devices sold worldwide as of March 31, 2013, noted the FDA.

Instructions for reporting problems and recommendations for physicians and patients are outlined in the advisory, which is available online on the FDA's website. The FDA's advisory is directed to pediatric and adult interventional cardiologists; cardiothoracic surgeons; noninvasive cardiologists; referring and follow-up physicians, including pediatricians; and patients implanted with the device.

According to the FDA advisory, tissue erosion caused by the Amplatzer ASO is rare, but can be life-threatening. 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 FDA noted that immediate open-heart surgery may then be necessary to remove the device, close the holes or other defects caused by erosion, and close the original defect the device was meant to treat less invasively. The FDA has not yet identified risk factors related to the occurrence of erosion.

According to the advisory, the FDA is requiring St. Jude Medical to conduct a study of patients who have been recently implanted with the device to better understand how erosion impacts the performance of the Amplatzer ASO and assess potential risk factors related to the occurrence of erosion. The study is designed to estimate the incidence of erosion events within 7 days, 1 month, 6 months, and 12 months after the implantation of the Amplatzer ASO. The study will also compare patients who experience an erosion event to those who do not, and will identify differences in demographic, clinical, and device characteristics, stated the FDA.