FDA WARNING_LETTER - SynCardia Systems LLC - August 18, 2017

The FDA issued a Warning Letter to SynCardia Systems, LLC, following an inspection from August 14-18, 2017, which found their SynCardia Temporary Total Artificial Heart (TAH-t) System to be misbranded.

The primary violation cited was the failure to report a device-related death within 30 calendar days, as required by 21 CFR 803.50(a)(1). Specifically, a post-approval study identified a patient death in March 2016 due to device malfunction, for which SynCardia failed to submit a Medical Device Report (MDR). The firm's reliance on customer reporting was deemed inadequate, and they failed to document efforts to obtain additional information.

Additionally, SynCardia failed to adequately develop, maintain, and implement written MDR procedures (21 CFR 803.17). Deficiencies included a lack of evidence of implementation (no effective/release date for the procedure), absence of internal systems for timely identification and evaluation of reportable events not originating from customer complaints, and insufficient documentation of decision-making processes for reportability determinations.

The FDA reviewed SynCardia's responses but found their adequacy undetermined, noting that while revised procedures and training were provided, evidence of implementation and retrospective review of adverse events was lacking.

SynCardia must take prompt corrective actions, including addressing systemic problems, and provide a written response within fifteen business days