BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)

    MDR report key: 11701301 · Received April 21, 2021

    Report

    Report Number
    3003761017-2021-00045
    Event Type
    Death
    Date Received
    April 21, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 16, 2021
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003008
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES OF THE DEVICE THAT WOULD IMPACT THE REPORTED EVENT. 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).

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT SUPPORT WAS WITHDRAWN FROM THE PATIENT ON (B)(6) 2021. THE CUSTOMER REPORTED THE CAUSE OF DEATH AS OTHER: SEIZURE ACTIVITY WITHOUT NEUROLOGICAL RECOVERY AND THAT THE TAH-T DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598626 SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 500101-001 119212 00858000003008

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death