St. Jude Amplatzer ASO Tissue Erosion Problems Result in FDA Warning

Government health officials have issued a warning about a risk of serious problems with a St. Jude cardiac implant instrument, which may create erosion around the heart, posing a risk of severe and life-threatening injuries that require immediate open heart surgery.  

The FDA announced a St. Jude Amplatzer Atrial Septal Occluder safety communication warning on October 17, after receiving more than 100 reports of the medical device scraping and eroding tissue around the upper chambers of the heart. To date no deaths have been associated with the device, but FDA adverse events typically only account for between 1% and 10% of all problems caused by medical devices.

The FDA investigation indicates that the device may cause erosion in about 1 to 3 cases out of every 1,000 patients implanted with the St. Jude Amplatzer ASO. According to the manufacturer, there have been 234,103 devices sold worldwide, suggesting that hundreds of individuals may have experienced tissue erosion problems from a St. Judge Amplatzer ASO.

St. Jude Amplatzer ASO Complications

The St. Jude Amplatzer Atrial Septal Occluder (ASR) is a metal device inserted into a vein around the heart to treat abnormal holes between the upper left and right chambers of the heart called Atrial Septal Defects (ASD). The device is used in both children and adults and is commonly accepted as an alternative to open heart surgery.

Medical experts have reported the device rubbing against the wall of the heart can erode existing tissue, specifically toward the top of the atria near the aorta which could cause additional holes in the aortic root.

Doctors have published reports in medical journals warning that if holes are created near the aortic root it may cause a blood accumulation around the heart and decrease its function, potentially leading to congestive heart failure. Erosion may also cause fistulas, which are abnormal scar tissue sealing areas of the heart that were not previously connected.

Treatment for erosion cases may be difficult because removal of the device is not recommended by the FDA. The agency warns that risks associated with removal surgery may be equal to or greater than the risk of erosion.

The FDA recommends that patients talk to their doctor about treatment programs and receive routine check-ups with their cardiologists following implantation to check for symptoms of erosion. Patients are also encouraged to tell their physician if they experience any chest pain, numbness, weakness, dizziness, fainting, shortness of breath, or abnormal heart rates as these symptoms could be associated with erosion.

Problems With Other St. Jude Heart Devices

This is not the first time a St. Jude medical device has been linked to potential heart problems. About two years ago, the company removed St. Jude Riata defibrillator leads from the market following reports that the insulation around the devices were failing, exposing the electrodes, which are implanted near, or in contact with, the heart. The problems have led to a number of St. Jude Riata lawsuits by former patients who were implanted with the defective heart wires.

The St. Jude Riata and Riata ST ICD leads are used to connect an implantable cardiac defibrillator (ICD) to the heart. The company decided to suspend sales of the leads more than two years ago, and then issued a warning to doctors in late 2011 about reports of insulation problems.

The FDA determined that the actions constituted a St. Jude Riata recall in December 2011. Approximately 227,000 St. Jude Riata wires were sold worldwide before it was removed from the market, and estimates suggest that approximately 79,000 of the leads remain active in patients in the United States, as the process of attempting to remove the lead is very risky and doctors usually recommend keeping the recalled lead in place unless there is evidence that it has failed.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.