A Word of Caution Risk of Device Erosion After Percutaneous Treatment of Atrial Septal Defect in Patients With Dilated Aortic Root

The US Food and Drug Administration has alerted providers and patients that the catheter-delivered Amplatzer atrial septal occluder (AGA Medical, Golden Valley, MN) from St. Jude Medical poses a small risk of potentially life-threatening complications.1 According to the agency, the device can erode the surrounding tissue over time and may cause cardiac tamponade or other complications that require immediate surgery. The agency estimates the risk of such emergencies at 1 to 3 per 1000 implanted patients and notes that >230 000 Amplatzer atrial septal occluder devices have been implanted around the world. 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 …