What Is An Amplatzer Septal Occluder?
An Amplatzer Atrial Septal Occluder (ASO) 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.
Why Can It Be Dangerous?
The Food and Drug Administration (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 ASO. As of March 31, 2013, there have been 234,103 ASO devices sold worldwide. Between 2002 and 2011, the FDA received more than 100 reports of erosions associated with the ASO. The FDA said these cases resulted in life-threatening emergencies that required immediate surgery.
I Have An ASO, Should I Worry?
The FDA does not recommend device removal for patients who have it, unless physicians determine it is appropriate for their particular patient. The FDA said the risks associated with device removal surgery may be equal to or greater than the risk of erosion. However, if erosion is suspected, patients should immediately go the emergency room for an echocardiogram. Patients should follow-up with their cardiologist after one and six months, and one year post-implantation. After the one year mark, patients should follow-up with their cardiologist once a year, unless there are symptoms or concerns.
What Are Symptoms Of Erosion?
Contact your doctor immediately if you have:
- Chest pain
- Sudden Weakness
- Shortness of Breath
- Rapid heartbeat
We Are Investigating These Claims
Milavetz, Gallop & Milavetz is investigating claims relating to the St. Jude Amplatzer Atrial Septal Occluder. If you or someone you know have been injured by an ASO, contact Milavetz, Gallop & Milavetz for a free consultation.