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

2007 – Research shows: ASOs may erode into flesh of heart

Posted in Atrial Septal Occluders

Many treatments have been created to remedy Atrial Septal Defects (ASD).  An ASD is a condition of the heart characterized by an opening between the left and right atria.  This opening between the two heart chambers can lead to low blood oxygen levels, as deoxygenated blood is not properly kept separated from oxygen rich blood before being pumped to the rest of the body.  One treatment for an ASD employs the use of an atrial septal occluder.  An occluder can be placed in the heart to seal the opening, without performing major surgery.  Complications have been reported following the implantation of an occluder to treat an ASD.  One common complication is a result of embolization due to aortic rim erosion.

Many studies have been conducted to identify risk factors of embolization and erosion.  One study conducted by M Misra et al. was published in The Journal of Interactive Cardiovascular Thoracic Surgery in 2007, and is titled “The ‘aortic rim’ recount: embolization of interatrial septal occluder into the main pulmonary artery bifurcation after atrial septal defect closure.”  In this case study the authors report a “rare complication of early embolization of the Blockaid septal occluder into the main pulmonary artery bifurcation associated with ‘aortic rim’ erosion”.  Furthermore the report provides additional information on complications associated with aortic rim erosion.

The case study reports a procedure performed on an 18 year old male, in which a septal occluder was successfully placed.  The study reports that the day after the procedure the participant had embolization of the device into the main pulmonary artery bifurcation. Emergency surgical retrieval of the device with closure of the ASD was performed.  At surgery the ASD was found to have an eroded aortic rim.

In their conclusion the researchers stated that the complications were due to “a combination of factors including an inadequate aortic rim; a grossly oversized device which eroded the aortic rim; and the Blockaid septal occluder, whose formally untested design and configuration could have led to its migration.”  They concluded that incidences of complications could be reduced with proper evaluation of the aortic rim, proper device size, and choice of the device.

Studies like this illustrating the danger of ASOs can be used in an ASO lawsuit to demonstrate to a court that the manufacturer of this device knew, or should have known, that its product was associated with cardiac erosion.

If you or a loved one used an ASO and suffered cardiac erosion or another atrial septal occluder side-effect, you may be entitled to significant financial compensation from the manufacturer of the device you used.  Many studies have been published on this subject and it is clear that these medical device companies ought to have been aware of the risks associated with their products.

For more information, or for a free, no-obligation ASO lawsuit consultation, contact our team of ASO lawyers at your convenience.  We have the experience, skills, and resources 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

justinian@dangerousdrugs.us

Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.