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 october 1, 2017 through december 31, 2018 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.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4), (b)(6).
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While supported by the tah-t, the patient experienced the following adverse events as defined by intermacs: 0 day post implant - bleeding.15 days post implant - neurological dysfunction - cva i location: cerebellar, lh: occipital, rh: occipital i severity: altered mental status.46 days post implant - neurological dysfunction - tia.50 days post implant - psychiatric episode.150 days post implant - infection i location: pump/related - exit cannula i type: bacterial.150 days post implant - respiratory failure.152 days post implant - renal dysfunction.The patient subsequently expired with a cause of death listed as multisystem organ failure (msof) after 157 days of tah-t support.
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