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: intermacs patient registry data collected from july 1, 2019 through september 30, 2020 regarding adverse events was 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.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.Ce (b)(4).
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While supported by the tah-t, the patient experienced the following adverse events as defined by intermacs: 3 days post implant - neurological dysfunction - cva i location: right hemisphere: temporal i severity: left sided paralysis.3 days post implant - respiratory failure.50 days post implant - infection i location positive blood cultures, line sepsis i type: bacterial.55 days post implant - psychiatric episode.127 days post implant - renal dysfunction.215 days post implant - neurological dysfunction - seizure.266 days post implant - neurological dysfunction - cva i location: cerebellar i severity: other.The patient subsequently received a heart transplant after 342 days of tah-t support.
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