SynCardia Heart Transplant Devices Continue To Show High Mortality Rates, FDA Warns

Federal health regulators warned doctors this week that a machine used during heart transplant surgery may be linked to a higher-than-expecterd number of deaths, posing a potential risk for certain patients. 

In the safety alert issued on September 25, the FDA provided an update on earlier information about potential problems with the SynCardia Systems TAH-t Companion 2 Driver System (C2) and Freedom Driver System. The agency reported that it has new data highlighting the risk of death associated with heart transplant device.

The new warning builds on the prior announcement, indicating the heightened risk of death in some patients is still an ongoing issue. Interim post-market studies indicate that a subgroup of patients may have a higher three-month mortality rate than other patients.

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The earlier heart transplant device warning was issued by the FDA in October 2016, indicating that the Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2) and the Freedom Driver System manufactured by SynCardia Systems, Inc. were causing serious side effects, including death, in some patients.

The TAH-t is a bridge to a heart transplant for some patients who have heart failure with severe bi-ventricular failure. However, some patients who underwent rescue efforts before using the system experience higher complications and death rates, the agency reports.

According to the FDA, some at-risk patients required pre-implant circulatory rescue interventions when using the TAH-t C2, when compared to patients who used a previous model, the Circulatory Support System (CSS).

The initial findings indicated nearly 40% of patients in that subgroup who used the TAH-t C2 system died within three months. Similarly, those patients had a higher risk of neurological adverse events, including transient ischemic attacks, hemorrhagic stroke, strokes from other causes, seizures, and encephalopathy. Their risk for these side effects was 31%, compared to 16% for those who used the CSS system.

Researchers noted that patients who did not need pre-implant circulatory rescue interventions did not face an increased risk of death.

The FDA first informed healthcare providers of the complication in a letter issued June 15, 2015.

As for the Freedom Driver System, a portable system which can be used outside the hospital setting, post-market studies found recent reports of serious life-threatening malfunctions of the system. One of those malfunctions involved a failure of pumping which did not set off the proper warning alarms.

The FDA update indicates these issues and risks are still ongoing, supported by recent interim post-market studies.

As part of the conditions for market approval, SynCardia was required to conduct ongoing studies concerning the safety of the systems after the products went on the market. The studies focus on comparing patients on the TAH-t C2 system to those on the CSS system.

The agency recommends doctors carefully weigh the results of the study before making treatment decisions for patients and return any device associated with adverse events to the manufacturer. They also warn doctors and patients should report any adverse events to the FDA MedWatch Adverse Event Reporting program.


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