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

2004 – Serious Complications Associated with Amplatzer ASO (St. Jude)

Posted in Atrial Septal Occluders

An Atrial Septal Defect (ASD) is a cardiac malformation, in which an opening between chambers in the heart did not properly close following birth.  This can be very problematic because it lowers oxygen levels in the blood; this happens as a result of oxygen deficient blood mixing with oxygen rich blood before being pumped out to the rest of the body.  One treatment involves using an “Amplatzer” Atrial Septal Occluder (ASO).  Implanting an ASO is a minimally invasive procedure, as the device is placed through a vein and does not require major surgery.  At the same time, there have been some instances of serious complications.  These complications can be fatal if not treated promptly.

Many studies have been conducted to analyze the risk factors involved with such cases.  One such study (published 2004) titled “Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk,” was conducted by Amin et al. and published in the Journal of Catheterization and Cardiovascular Interventions.  The authors stated “The objectives of this study were to identify possible risk factors that may lead to erosion of the Amplatzer septal occluder (ASO) and recommend ways to minimize future risk.”

Instances of adverse events after ASO placement are quite rare.  Identifying common factors of high risk cases may allow for early recognition of complications and prompt intervention could minimize the frequency of adverse outcomes.  In this study, echocardiograms, ASD size, size of the device used, cineangiograms, and operative records were collected from cases in which complications developed.  These factors were reviewed and analyzed to determine which most commonly occurred in patients who suffered from complications.

The authors of the study concluded “Patients with deficient aortic rim and/or superior rim may be at higher risk for device erosion. Oversized ASO may increase the risk of erosion. The defect should not be overstretched during balloon sizing.”  While complications are rare, incidences can be decreased by identifying high-risk patients and following them closely after placement of the ASO.

Because many people have experienced these rare but serious side effects of ASO use, a number of Amplatzer lawsuits have been filed.  If you or a loved one used an amplatzer, particularly those manufactured by St. Jude, you may be entitled to significant financial compensation for your injury.

For more information on amplatzer lawsuits, or a free, no-obligation ASO lawsuit consultation, please do not hesitate to contact our team of ASO lawyers at the information provided below.

(855) 452 – 5529

justinian@dangerousdrugs.us

We have the experience, resources, and skills required to win the justice you deserve.  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.