SynCardia—Companion 2 and Freedom Driver Systems Used with Temporary Total Artificial Hearts: Freedom Driver Systems May Malfunction; Higher Neurological Adverse Event Rates for Companion 2

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In an October 26, 2016, Letter to Healthcare Providers and an October 26, 2016, Safety Alert, FDA states that it is aware of recent reports of serious, life-threatening TAH-t device malfunctions involving the above Freedom driver systems and that these reported malfunctions have included sudden cessation of TAH-t pumping without warning alarms or recognizable signs of impending malfunction (e.g., a change in sound during the driver system's operation).

In addition, FDA states that since it posted a June 15, 2015, letter informing the healthcare community that preliminary post-approval study information suggested a higher mortality rate for a subgroup of patients requiring preimplant circulatory rescue interventions when using the above C2 driver system with the above TAH-ts as compared to the previous generation driver (the Circulatory Support System CSS Console), there has continued to be a higher mortality rate for this subgroup of patients when using the C2 driver compared to those using the CSS Console. The mortality rate for patients who did not require preimplant circulatory rescue interventions was similar for the C2 driver system compared to the CSS Console. For details on these mortality rates see the Mortality Results section of FDA's Letter to Healthcare Providers, and specifically Tables 1 and 2. FDA also states that additional interim post-approval study results have also indicated a higher risk of neurological adverse events for patients supported by the C2 driver system compared to patients supported by the CSS Console. FDA further states that the INTERMACS Neurological Adverse Event (AE) rate (which is a composite of several separate adverse events, including: transient ischemic attacks, confusion, ischemic/embolic stroke, hemorrhagic stroke, strokes from other causes, seizures, encephalopathy, and other events) in the first 3 months post-implant is higher for patients initially supported by the C2 driver system (31%) compared to patients initially supported with the CSS Console (16%). For details on these results, see Table 3 in FDA's Letter to Healthcare Providers. FDA states that these results are not adjusted for potential confounders, and they were not further stratified by pre-implant circulatory rescue intervention status. The manufacturer has not confirmed the...