FDA Reports Serious Erosion Events With Amplatzer Septal ... | 合法醫療器材資訊網

TheAmplatzerASDclosuredeviceispassedthroughaseptaldefectandis...(​ASDs),butarefrequentlyusedoff-labeltotreatpatentforamenovales(PFO).

The U.S. Food and Drug Administration (FDA) issued a warning this week about safety issues encountered with the St. Jude Amplatzer Atrial Septal Occluder (ASO). The transcatheter device is used to seal congenital holes in the atrial septum. The FDA reported in a rare safety communication that the device may cause life-threatening tissue erosion inside the heart. 

Between 2002 and 2011, the FDA received more than 100 reports of erosions associated with the Amplatzer ASO. During the same period, several medical journals contained articles reporting tissue erosion among patients implanted with this device. The FDA said these cases resulted in life-threatening emergencies that required immediate surgery.

The device is made of a self-expanding nitinol metal mesh, which if the device is sized improperly, will rub against the wall of the heart a...