SYNCARDIA SYSTEMS, LLC SYNCARDIA 50CC OR 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE
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Catalog Number 570500-001 OR 500101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemolysis (1886); Hemorrhage/Bleeding (1888); Renal Impairment (4499); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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While supported by the tah-t, the patient experienced the following adverse events as defined by intermacs: 2 days post implant - bleeding, 3 days post implant - renal dysfunction, 6 days post implant - hemolysis, 18 days post implant - device malfunction and/or pump thrombosis, 19 days post implant - hemolysis, 34 days post implant - infection, 40 days post implant - neurological dysfunction, 52 days post implant - bleeding.The patient subsequently received a heart transplant after 91 days of tah-t support.
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Manufacturer Narrative
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The syncardia 50 cc or 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 50 cc or 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.Investigation summary: intermacs patient registry data collected from (b)(6) 2022 regarding adverse events was reviewed.Patients were de-identified therefore a one-ton-one correlation could not be made between the patient and the lot number of the implanted heart.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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