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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results
UPDATED 09/25/2017. The FDA issued an update to the October 2016 letter to healthcare providers, to inform the health care community of the most recent, interim results from the ongoing SynCardia TAH-t post-approval study that is looking at mortality and neurological adverse events. These interim results continue to reflect a higher three-month 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 continued to be similar for the C2 Driver System compared to the CSS Console.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the letter to healthcare providers, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526703.htm
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