BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA 70CC TAH-T

    MDR report key: 7078771 · Received December 4, 2017

    Report

    Report Number
    3003761017-2017-00226
    Event Type
    Death
    Date Received
    December 4, 2017
    Date of Event
    November 5, 2017
    Report Date
    November 7, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003008
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 CERTIFIED HOSPITAL, REPORTED THE PATIENT EXPIRED ON (B)(6) 2017 FROM MULTI-ORGAN SYSTEM 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
    859333 SYNCARDIA 70CC TAH-T BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 500101-001 109910 00858000003008

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death