BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA 50CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)

    MDR report key: 11832382 · Received May 17, 2021

    Report

    Report Number
    3003761017-2021-00094
    Event Type
    Death
    Date Received
    May 17, 2021
    Date of Event
    May 9, 2021
    Report Date
    May 13, 2021
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003053
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYNCARDIA 50CC 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 50CC 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) INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2021. THE CUSTOMER REPORTED THE CAUSE OF DEATH AS MULTI-ORGAN SYSTEM FAILURE AND INDICATED THAT THE TAH-T 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727448 SYNCARDIA 50CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 114999 00858000003053

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death