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 70 cc 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 70 cc 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)(6).
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A retrospective review of intermacs de-identified data collected between september 22, 2015 and september 30, 2017 revealed that a patient expired with a cause of death listed as circulatory: end stage cardiomyopathy.The intermacs data listed that the tah-t functioned normally.The intermacs data listed that the tah-t was not explanted.
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