The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Amplatzer Atrial Septal Occluder (ASO), manufactured by St Jude Medical.
The 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. As of 31 March 2013, there have been 234,103 Amplatzer ASO devices sold worldwide.
According to the FDA, 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 device rubbing against the wall of the heart can erode the tissue and create a hole. It can also lead to further scraping or erosion through tissue in the upper chambers (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 sac surrounding the heart (cardiac tamponade). If too much blood builds up in this sac, the heart will not be able to work properly.
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. Tissue erosion can also cause fistulas - abnormal scar tissue that connects parts of the heart that were not previously connected. Fistulas are not life-threatening, but do require surgery for treatment and could result in congestive heart failure.
The FDA does not recommend device removal for patients who have the Amplatzer ASO 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. In addition, the FDA is requiring St. Jude to conduct a study of patients who have been recently implanted with the device so as to better understand how erosion impacts the performance of the Amplatzer ASO and assess potential risk factors related to the occurrence of erosion.
For details, please visit the following FDA websites:
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 October 2013