The syncardia 70cc temporary total artificial heart (tah-t) is an implantable pulsatile biventricular replacement device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation systems.The syncardia 70cc tah-t is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.The syncardia tah-t system is intended for use inside and outside the hospital.Investigation summary: (b)(6) patient registry data collected between (b)(6) 2014 and (b)(6) 2017 regarding adverse events was retrospectively reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the implanted tah-t.These events were assessed and are being reported in response to an update to the mdr complaint sources.With a review of the available information, there is no evidence of a device malfunction or performance issues that would impact the reported events.Possible clinical factors that may have contributed to these events include the patients pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulants, antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to these events.This device is used for treatment, not diagnosis.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).
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While supported by the tah-t, the patient experienced the following adverse events as defined by (b)(6): 2 days post implant - pericardial drainage; 9 days post implant - infection/location: pulmonary/type: bacterial; 16 days post implant - renal dysfunction; 18 days post implant - respiratory failure; 24 days post implant - hepatic dysfunction; 37 days post implant - bleeding; 38 days post implant - hepatic dysfunction; 59 days post implant - hepatic dysfunction; 59 days post implant - infection/location: positive blood cultures, pulmonary/type: bacterial; 60 days post implant - neurological dysfunction - cva/location: other/severity: coma.The patient subsequently expired with a cause of death listed as nervous system: neurological dysfunction after 60 days of tah-t support.
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