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 a tah-t, the patient has experienced the following adverse events as defined by intermacs: 1 day post implant - neurological dysfunction- seizure 13 days post implant - neurological dysfunction - cva i location: rh: frontal i severity: other 16 days post implant - infection i location: gi i type: bacterial.16 days post implant - renal dysfunction.7 days post implant - infection i location: pulmonary i type: bacterial.As of june 30, 2019 it was reported that the patient was still supported by a tah-t.
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Additional information has been provided in section b5.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 inmplanted tah-t.Ce 5519 pt 120945 follow-up report 1.
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