Important Safety Alerts

The United States Food and Drug Administration (FDA) is providing an update and additional information regarding SynCardia Systems, Incorporated's Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System), as well as to inform health care providers of recent events with an additional SynCardia pneumatic driver system, the Freedom Driver System.

As a condition of approval of the C2 Driver System, the FDA required the manufacturer to conduct a post-approval study assessing post-market performance. The study relies on data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), and compares outcomes for patients who were initially supported with the C2 Driver System and the Circulatory Support System (CSS) Console during the same time period (implanted on 20 Jun 2012 or after).

The most recent results from the ongoing post-approval study regarding mortality and neurological adverse events are in the letter to health care providers. (Link:
http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm526515.htm)

According to the FDA, there has continued to be a higher mortality rate for the subgroup of patients requiring pre-implant circulatory rescue interventions when using the C2 Driver System compared to those using the CSS Console. The mortality rates for patients who did not require pre-implant circulatory rescue interventions were similar for the C2 Driver System compared to the CSS Console. In additional, the most recent post-approval study results suggest that there is also a difference in clinical performance between the C2 Driver System and the CSS Console in terms of neurological adverse events.

The FDA has the following recommendations for health care providers:

• Carefully consider these mortality and neurological adverse event results, and device malfunction reports when making treatment decisions and device selection, and discuss the risks and benefits of these devices with patients.
• Report any adverse events or suspected adverse events experienced with the SynCardia TAH-t Driver Systems (the C2 Driver, the CSS Console, or the Freedom Driver).
• Return all devices associated with, or suspected to be associated with, any adverse events to the manufacturer for evaluation.

For details, please refer to the FDA website:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526703.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 27 October 2016