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 january 1, 2019 through june 30, 2019 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.(b)(4).
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While supported by the tah-t, the patient experienced the following adverse events as defined by intermacs: 121 days post implant - bleeding, 150 days post implant - infection i location: positive blood cultures i type: bacterial, 161 days post implant - bleeding, 161 days post implant - other sae, 179 days post implant - bleeding, 179 days post implant - infection i location: other i type: viral, 189 days post implant - bleeding, 204 days post implant - bleeding, 224 days post implant - infection i location: positive blood cultures i type: bacterial, 32 days post implant - neurological dysfunction- encephalopathy, 32 days post implant - other sae, 32 days post implant - respiratory failure, 41 days post implant - renal dysfunction, 58 days post implant - bleeding, 71 days post implant - device malfunction and/or pump thrombosis, 83 days post implant - venous thromboembolism.The patient subsequently expired with a cause of death listed as multisystem organ failure (msof) after 254 days of tah-t support.
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