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2009 – Study shows rare, but deadly complications associated with Amplatzer atrial septal occluder

Posted in Atrial Septal Occluders

An atrial septal defect (ASD) is a condition of the heart characterized by an opening that failed to close after birth.  The opening is located between the left and right atria, which are two of the four chambers in the heart.  When the opening between these chambers exists it allows de-oxygenated blood to mix with oxygenated blood before being pumped to the rest of the body.  This may result in insufficient oxygen being delivered to the rest of the organs.  One treatment for this condition involves using an “Amplatzer” Atrial Septal Occluder (ASO).  The ASO is implanted into the heart, and seals the opening between the two atria, without performing major surgery.  Complications due to erosion are rare, however they may be fatal if not treated promptly.

Instances of complications have been reviewed and guidelines regarding ASO implantations have been revised based on these reviews.  HG El-Said and JW Moore conducted a study published in a 2009 edition of the Journal of Catheterization and Cardiovascular Interventions, titled “Erosion by the Amplatzer septal occluder: experienced operator opinions at odds with manufacturer recommendations?”  The authors state, “The aim of our study is to help define an expanded expert consensus with respect to the causes and preventive strategies for erosions.”  In this report, the researchers analyzed the results from an ASO implantation case study that closely followed the expert’s guidelines in addition to a survey of the Congenital Cardiovascular Interventional Study Consortium collecting the opinions and experiences from experts who have used ASOs.

The survey reported 14 total erosions out of 3,010 implants.  Deficit aortic rims were observed in 90% of erosions.  Other factors that increased the rate of erosion were undersized devices that do not straddle the aorta and motion of the device relative to the heart.

The authors concluded “Both the survey results and our single case experience suggest that operator opinions (and perhaps also device sizing practices) are at odds with the 2004 revisions.   While the authors purport that further study and focus on this issue is needed, many people have experienced the negative side effects of ASO use already.

Due to the fact that St. Jude, a large medical device manufacturer that makes many ASO devices, has failed time and again to warn the public of the risks associated with ASOs, a number of St. Jude Amplatzer lawsuits have been filed.  If you or a loved one used an ASO an experienced one of these negative side effects, you may be entitled to significant financial compensation for the injuries you sustained through no fault of your own.

For more information on Amplatzer lawsuits or a free, no-obligation case consultation, contact our team of Amplatzer lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!  Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.