BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA 70CC TAH-T

    MDR report key: 7019542 · Received November 10, 2017

    Report

    Report Number
    3003761017-2017-00199
    Event Type
    Death
    Date Received
    November 10, 2017
    Date of Event
    September 4, 2017
    Report Date
    October 12, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. THE TAH-T WAS NOT EXPLANTED AND THEREFORE 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).

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THE PATIENT EXPIRED ON SEPTEMBER 4, 2017 FROM MULTI-ORGAN FAILURE. THE CUSTOMER ALSO REPORTED THAT THE TAH-T WAS NOT EXPLANTED AND NO AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801417 SYNCARDIA 70CC TAH-T BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 108294

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death