Catalog Number P/N 500101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/07/2022 |
Event Type
Death
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Manufacturer Narrative
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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.Based on the provided information there is no indication of a device malfunction or performance issue of the device that would impact the reported event.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.
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Event Description
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On 12dec2022 syncardia received the outcome form which did not list a cause of death for ospedale monaldi - napoli patient (b)(6) on (b)(6) 2022, and that the device did not cause or contribute to the patient's death.The tah-t was not explanted and no autopsy was performed.No additional information has been provided at this time.
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Search Alerts/Recalls
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