BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 12094619 · Received June 30, 2021

    Report

    Report Number
    3003761017-2021-00124
    Event Type
    Death
    Date Received
    June 30, 2021
    Date of Event
    June 1, 2021
    Report Date
    September 10, 2021
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003008
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE 70CC TAH-T HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. CE (B)(4) FOLLOW-UP REPORT 1.

    Description of Event or Problem · 0

    SYNCARDIA RECEIVED THE MEDWATCH FORM SUBMITTED BY VCU RISK MANAGEMENT AND IT CONTAINED INFORMATION REGARDING THE PERFORMANCE OF THE TAH-T THAT WAS PREVIOUSLY UNREPORTED TO SYNCARDIA - "POST SURGERY, NOTED TO HAVE LOW FLOW ON HIS TOTAL ARTIFICIAL HEART WITH POOR OXYGENATION AND VENTILATION". SYNCARDIA SENT A SECOND REQUEST TO VCU FOR THE RETURN OF EXPLANTED 70CC TAH-T L/N 105701 AND IT WAS GRANTED BY VCU RISK MANAGEMENT WITH THE CONDITION THAT SYNCARDIA PROVIDE VCU HEALTH WITH A REPORT OF THE FINDINGS UPON COMPLETION OF SYNCARDIA EVALUATION.

    Additional Manufacturer Narrative · 1

    PATIENT (B)(6) IS A STUDY SUBJECT IN THE (B)(6) STUDY WITH CUMULATIVE 1931 DAYS OF SUPPORT. 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) INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT HAD TESTED POSITIVE FOR CORYNEBACTERIUM IN (B)(6) 2021 AND THIS WAS THE SAME BACTERIA ATTRIBUTED TO HIS CHRONIC DRIVELINE INFECTION. THE CUSTOMER ALSO REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2021. THE CUSTOMER REPORTED THE CAUSE OF DEATH AS OTHER: ASPIRATION WITH CAUSES OR CONTRIBUTING FACTORS TO THE DEATH AS SMALL BOWEL OBSTRUCTION AND CHRONIC DRIVELINE/PUMP INFECTION. THE CUSTOMER ALSO STATED THAT THE TAH DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH; AT THE TIME OF HIS DEATH, HIS CULTURES WERE NEGATIVE. THE TAH WAS EXPLANTED AND A LIMITED AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988234 SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 500101-001 105701 00858000003008

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| H