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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2013 – Study seeks early warning signs of erosion in ASO use

Posted in Atrial Septal Occluders

Atrial Septal Defect (ASD) is a rare malformation of the heart in which there is an opening between two chambers of the heart.  Typically, this opening closes after birth; ASD is when the opening fails to close.  As a result, people with ASD have abnormally low blood oxygen levels because blood oxygen rich blood is mixing with low oxygen blood.  One treatment for this condition employs the use of an Atrial Septal Occluder (ASO), which seals the opening between the two chambers. ASO implantation is minimally invasive, and doesn’t require major surgery because the device is implanted through a vein.  ASO usage has unfortunately led to numerous complications because of erosion after implantation.  These complications can be fatal if they are not treated on time.

Studies have set out to explore the risk factors associated with ASO usage.  One study titled “Echocardiographic predictors of cardiac erosion after amplatzer septal occluder placement” was conducted by Amin Z, and published in Pubmed.  The two factors that appear to cause complications are Aortic rim deficiency and the use of over-sized ASOs.  The author states that this study “attempts to describe device characteristics, anatomical features and echocardiographic predictors that increase the risk of erosion.”

This study included 12 new cases and evaluated a number of parameters that could have potentially caused complications such as ASD location (high or low), rims deficiency and consistency, septal mal-alignment, dynamic nature of the defect; device edge relationship toward the transverse sinus (TS), atrial free wall tenting and the size of the defect compared with the size of the device used for closure.

The results of the study showed that multiple factors did in fact contribute to complications.  “Aortic rim absence in multiple views, poor posterior rim consistency, septal mal-alignment, and dynamic ASD appear to be factors where erosion risk increases significantly.”  The author also states that the 26-mm device had the highest rate of erosion.

Due to the fact that many people have used amplatzer devices manufactured by St. Jude unaware of the risk for erosion associated with ASOs, a number of St. Jude Amplatzer ASO lawsuits have been filed.  If you or a loved one has used an ASO and experienced negative amplatzer side effects, please do not hesitate to contact our team of amplatzer ASO lawyers at the information provided below.

(855) 452 – 5529

justinian@dangerousdrugs.us

We have the skills, resources, and experience required to win the justice you deserve.  Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.