Medical Device Safety and Recalls: Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO)

AUDIENCE: Cardiology, Risk Manager, Patient

ISSUE: 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 March 31, 2013, there have been 234,103 Amplatzer ASO devices sold worldwide.

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.

BACKGROUND: The St. Jude Amplatzer Atrial Septal Occluder is a cardiac implant device used in children and adults to treat an abnormal hole between the upper left and right chambers (atria) of the heart, known as an atrial septal defect (ASD). The metal device is put into place through a thin tube (catheter) inserted into a vein. This is considered a minimally invasive method for ASD closure, and is an alternative to open heart surgery.

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.

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 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.

RECOMMENDATION: Healthcare professionals should review the updated Instructions For Use (IFU) for the Amplatzer ASO before implanting the device. Consider the potential for erosion when talking to patients about long- and short-term benefits and risks of treatment options, including implantation with the Amplatzer ASO. 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 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. See the FDA Device Safety Communication for additional information and recommendations.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178