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Following heart surgery where a contaminated 3T Heater-Cooler System was used, a Pennsylvania man indicates that he developed a devastating infection, with doctors noting the growth of “vegetation” on his recently replaced heart valve, according a product liability lawsuit filed against the manufacturer of the device.
The complaint (PDF) filed by Robert and Jean Jones in the U.S. District Court for the Eastern District of Pennsylvania on February 23, indicating that Livanova and Sorin Group distributed tainted heart surgery devices to hospitals worldwide, resulting in hundreds, and perhaps thousands, of similar infections.
The 3T Heater-Cooler is a surgical device commonly used during open heart surgery, which has been linked to problems with nontuberculous mycobacterim (NTM) infections, which may develop months or even years after surgery
The devices are used to regulate blood temperature during surgery. However, in late 2015, it was discovered that certain 3T Heater-Cooler systems were contaminated with bacteria, which is then released in a mist that may enter the sterile surgical site.
The bacteria may cause difficult to treat internal infections, which typically do not surface until long after exposure. As a result of the risk, hospitals nationwide have sent letters to thousands of heart surgery patients who may have been exposed to a contaminated 3T Heater-Cooler, recommending continued medical monitoring.
According to the lawsuit filed on behalf of Robert Jones and his wife, a contaminated 3T Heater-Cooler was used during a bio-prosthetic mitral valve replacement in August 2015. However, in June 2017, nearly two years later, Robert Jones began to display stroke-like symptoms and suffered fatigue and weight loss and was admitted to an emergency room.
“During this admission, a transesophageal echocardiogram revealed vegetation on Robert Jones’ mitral heart valve,” the lawsuit states. “Physicians also noted pancytopenia, persistent fevers, rapidly deteriorating liver function and splenomegaly.”
Even after experiencing those problems, it took another four months before doctors were able to diagnose Jones as having an M. Chimaera infection. In the meantime he was given antibiotics, continued to suffer health problems, and was treated for failure to thrive. During those months, scans continued to show worsening vegetation on his mitral valve.
Jones also suffered antibiotic-induced end stage kidney disease, liver toxicity, severe malnutrition, and lost nearly 100 pounds.
Jones was ultimately told by his doctors that antibiotics alone were not enough to get rid of his infection, and that even another valve replacement was not able to guarantee the infection would be completely removed.
In November, Jones was informed that his infection was likely caused by a contaminated 3T Heater Cooler System. He has since suffered kidney failures, sepsis, acute kidney injury, pancreatitis, and other health problems. His doctors have recommended that he enter palliative care, and he is suffering deteriorating mental status, and difficulty speaking.
The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
In 2016 the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.
The complaint filed by Jones is one of a growing number of other open heart surgery infection lawsuits filed nationwide over the 3T Heater-Cooler, alleging that the manufacturers knew about the risk of contamination and failed to adequately warn the medical community, the FDA, and patients of the risks.
All of the complaints filed in federal courts nationwide have been transferred to the U.S. District Court for the Middle District of Pennsylvania, where U.S. District Judge John E. Jones III has been assigned to coordinate discovery and pretrial proceedings.