Model Number 500101-001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Death (1802)
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Event Date 02/02/2019 |
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.The tah-t was not explanted, therefore it was not returned to syncardia for evaluation.Based on the provided information there is no evidence to indicate any device malfunctions or performance issues of the device that would impact the reported event.A definitive root cause cannot be conclusively determined.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4) initial.
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Event Description
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The customer, a syncardia authorized distributor, reported that the patient passed away on (b)(6) 2019.The customer reported the cause of death as avc/stroke.The customer also reported that the tah-t was not explanted and no autopsy was performed.No additional information has been provided at this time.
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Manufacturer Narrative
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(b)(4) follow-up report 1.
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Search Alerts/Recalls
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