St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication
MedSun: Newsletter #89, November 2013
FDA MedWatch Safety Alert
FDA is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO 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. The device rubbing against the wall of the heart can erode the tissue and create a hole. Healthcare professionals should review the updated Instructions For Use (IFU) for the Amplatzer ASO before implanting the device.
St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication. FDA MedWatch Safety Alert. October 17, 2013.