SynCardia Heart Transplant Devices Linked To High Mortality Rate, Malfunctions, FDA Warns

Two medical devices used to assist heart transplant patients may carry a serious risk of neurological adverse events, malfunctions and a higher than expected rate of death, according to new warnings. 

The FDA issued a letter to health care providers on October 26, notifying transplant surgeons and cardiologists about the potential risks associated with SynCardia Systems, Inc.’s Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System) and the SynCardia Freedom Driver System.

According to the warning, the C2 driver system appears to be linked to an increased mortality rate and increased risk of stroke and other neurological events, while the Freedom Driver System has been linked to reports of malfunctions that could put patients at risk.

Both the C2 Driver System and the Freedom Driver System are penumatic systems used to power the TAH-t, which is used before patients receive a heart transplant as a circulatory rescue intervention, meaning it does the work of the heart while patients await a new one. It is specifically used in heart failure patients with severe bi-ventricular failure.

When the FDA approved the C2 Driver System, it did so requiring SynCardia to conduct a post-approval study. Data from that study suggests that, when compared to another driver system known as the CSS Console, the C2 Driver System had a higher rate of mortality and a higher number of strokes, seizures, encephalopathy, and other events. The FDA found that 31% of patients who were supported by the C2 Driver System suffered neurological events, compared to only 16% on the CSS Console.

The FDA also warned that it has received reports of serious, life-threatening device malfunctions involving the Freedom Driver System, which is a portable device allowing some prospective heart transplant patients to return home while on the TAH-t. The reports include malfunctions where the system stopped pumping, or began to show signs that it was about to malfunction, such as sudden changes in the sounds it made during operation.

The agency notes that there was a Freedom Driver System class 1 recall in August 2015, but that these new problems appear unrelated.

The FDA is recommending that health care providers consider these findings and discuss the risks and benefits of these devices with patients. The FDA also asks that health care professionals report any adverse events lined to SynCardia TAH-t Driver Systems to the agency’s MedWatch adverse event reporting program and return any devices liked to adverse events to the manufacturer to aid in evaluation of these problems.