WARNING: Research shows that the “Amplatzer” Atrial Septal Occluder (ASO) (St. Jude Medical, Inc.) may fail and erode into the flesh of the heart causing heart attack and a life-threatening medical emergency.  

Atrial septal occluders are small metal mesh rings inserted intravenously to repair an atrial septal defect (ASD).  ASD is a congenital malformation characterized by an opening between the left and right atria (two of the four chambers in the heart)  that failed to close after birth.   If the opening between these chambers exists, de-oxygenated blood mixes with oxygenated blood before being pumped to the rest of the body, and this may result in insufficient oxygen being delivered to the rest of the organs.

When the device fails and the ASO erodes into the flesh of the heart, it is highly dangerous, often results in cardiac infarction (heart attack), and almost always constitutes a medical emergency.

FDA: St. Jude Amplatzer ASO linked to rare, deadly complications

On October 17th, 2013, the US Food and Drug Administration published a report – “St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication – Reports of Tissue Erosion” – where it is stated 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”

“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.”

Studies Show: Cardiac erosion “rare but serious complication” of St. Jude Amplatzer

Medical researcher Dr. Geoffrey B. Crawford, lead author of a 2012 study titled “Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature” published in Journal of Catheterization and Cardiovascular Interventions states that “Cardiac erosion is a rare but serious complication of the ASO device. Erosion events are most often ascribed to device over-sizing or deficient retro-aortic rims; however, both consensus and evidence for a cogent risk factor(s) is lacking.”

Another study, published in a 2009 edition of Journal of Catheterization and Cardiovascular Interventions, titled “Erosion by the Amplatzer septal occluder: experienced operator opinions at odds with manufacturer recommendations?” found that 14 of 3,010 Amplatzer ASOs resulted in cardiac erosion.  Though this shows that the absolute risk of Amplatzer erosion is low — Amplatzer ASO erosion is rare — Amplatzer erosion is serious when it does occur.

Published in 2013, a study by Z. Amin et al. titled “Echocardiographic predictors of cardiac erosion after amplatzer septal occluder placement” attempted to determine risk factors for ASO cardiac erosion, and determined that “Aortic rim absence in multiple views, poor posterior rim consistency, septal mal-alignment, and dynamic ASD” were risk factors in which “erosion risk increases significantly.”  Amin (2013) also writes that the 26-mm Amplatzer ASO had the highest rate of erosion.

St. Jude Amplatzer ASO Lawsuits

Due to the fact that St. Jude Medical, Inc. has failed time and again to warn users of the risk for ASO erosion associated with its Amplatzer ASO devices, a number of ASO lawsuits are currently being filed.  If you or a loved one used a St. Jude Amplatzer ASO and suffered ASO erosion, you may be eligible to file an Amplatzer ASO lawsuit and gain significant financial compensation for the pain and suffering you endured through no fault of your own.

For more information, or for a free, no-obligation Amplatzer ASO lawsuit consultation, contact our team of St. Jude Amplatzer ASO erosion lawyers by phone or e-mail at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve, even from the largest of medical device manufacturers.  Call today and see how we can help!

(855) 452 – 5529


Also, every post we’ve written about the Amplatzer Atrial Septal Occluder is available here.