Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

St. Jude Amplatzer ASO fails in 7.8% of cases

Posted in Atrial Septal Occluders

An Atrial Septal Defect (ASD) is a cardiovascular birth malformation.  The condition is characterized by an opening between two chambers of the heart, the left and right atria.  This opening closes after birth in healthy individuals but may fail to close for others, thus forming an ASD.  An ASD is problematic because it causes low blood oxygen levels due to deoxygenated blood passing through the opening, and mixing with oxygen rich blood before being pumped out of the heart.  The condition may be treated with an Amplatzer Septal Occluder (ASO), which seals the opening without requiring major surgery.  ASO’s have been effective in treating the defect, but there have been a number of reports of complications after implantation.  One major issue that has caused complications is selection of the proper size of the device.

One study that set out to investigate more about ASD sizing was conducted by M Zanchetta and published in The International Journal of Cardiology in 2004.  The study is titled “On-line intracardiac echocardiography alone for Amplatzer Septal Occluder selection and device deployment in adult patients with atrial septal defect.”  The author stated “For the Amplatzer Septal Occluder (ASO) device, accurate balloon sizing is considered of paramount importance because the prosthesis waist has to be exactly adjusted to the defect diameter (+/-1 mm).”  (Hyperlink added.)

The purpose of this study was to explore the effectiveness of different sizing techniques, and to evaluate the consequences of using an improperly-sized ASO: “In this study, we aimed to demonstrate the possibility of marked misinterpreting of the actual defect size using the balloon technique in patients with secundum ASD and to evaluate the accuracy of intracardiac echocardiography (ICE) measurements.”

The study included 166 patients who underwent percutaneous transvenous secundum ASD occlusion using the ASO device, while an additional 124 ASD closures were performed using conventional methods.  The results showed that successful implantation was accomplished in 163 out of 166 patients.  Successful occlusion was demonstrated in 92.2% of ASO procedures.

In my opinion, a failure rate of 7.8% is too high.  That aside, what is more important is that patients be aware of the risks associated with any and all medical procedures executed on their behalf.  Due to the fact that many people have undergone Amplatzer ASO operations unaware of the risk for cardiac erosion associated with the Amplatzer device, a number of Amplatzer lawsuits have been filed against the manufacturer, St. Jude Medical, Inc..  Many peer-reviewed scientific studies have demonstrated that cardiac erosion can occur with the Amplatzer, but St. Jude has not made this risk clear to patients.

If you or a loved one used an ASO, or the Amplatzer ASO by St. Jude, and suffered cardiac erosion or another ASO side-effect, you may be entitled to financial compensation from the manufacturer of your device.  For a free, no-obligation case consultation, contact our team of Amplatzer ASO lawyers at the information provided below.

(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.