Investigation summary: 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 this event 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 this event.This device is used for treatment, not diagnosis.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.This event was assessed and is being reported as part of a retrospective review of events in response to an update to the mdr complaint sources.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 for 28 days, the patient experienced the following adverse events as defined by intermacs: at 2 days post implant - renal dysfunction; 2 days post implant - device malfunction and/or pump thrombosis; 3 days post implant - arterial non-cns thromboembolism; 3 days post implant - neurological dysfunction - cva/location: bilateral: frontal, cerebellar, right hemisphere: temporal/severity: coma; 7 days post implant - neurological dysfunction - cva/location: other/severity: altered mental status; 9 days post implant - bleeding; 9 days post implant - pericardial drainage; 9 days post implant - respiratory failure; 15 days post implant - hepatic dysfunction; 20 days post implant - other sae; 21 days post implant - bleeding; 22 days post implant - other sae.
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