FDA Warns of Small Risk With St. Jude Heart Device

The U.S. Food and Drug Administration (FDA) has issued a safety communication about the risk of tissue erosion with St. Jude Medical Inc.’s Amplatzer Atrial Septal Occluder.

In “very rare” cases, the tissue around the device — which plugs an atrial septal defect — can start to break down, causing fistula, holes in the atria, or holes in the aortic root, which could result in cardiac tamponade. The life-threatening issue requires surgery to correct.

According to the FDA, the problem occurs in an estimated one to three out of every 1,000 patients implanted with the device. As of March, 234,103 occluders had been sold worldwide. The agency said it received more than 100 reports of erosions associated with the St. Jude Amplatzer ASO between 2001 and 2011, and it noted that several medical journals reported tissue erosion among patients implanted with the device.

 “To better understand how erosion impacts the performance of the Amplatzer ASO and assess potential risk factors related to the occurrence of erosion, the FDA is requiring St. Jude to conduct a study of patients who have been recently implanted with the device,” the agency said. “The study is designed to estimate the incidence of erosion events within seven days, one month, six months, and 12 months after the implantation of the Amplatzer ASO.”

The FDA did not recommend removing the device unless it was deemed appropriate for an individual patient because the removal surgery carries risks that might exceed the risk of tissue erosion. The agency said that physicians should read updated instructions for use before implanting the device and discuss the potential issue with patients when considering the risks and benefits.

“Educate patients implanted with the Amplatzer ASO to seek immediate medical attention if they develop symptoms such as chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat,” the agency said.