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.

Additional Information:

St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication. FDA MedWatch Safety Alert. October 17, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371202.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun