BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 1405115 · Received June 19, 2009

    Report

    Report Number
    3003761017-2009-00026
    Event Type
    Death
    Date Received
    June 19, 2009
    Date of Event
    June 12, 2009
    Report Date
    June 18, 2009
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXCOR DRIVERS AND EXCOR ACCESSORY KIT INCLUDING THE LAPTOP, WILL BE SENT TO MFR FOR INVESTIGATION. CARDIOWEST TAH-T LOT 63068 WILL BE EXPLANTED AND SENT TO SYNCARDIA FOR INVESTIGATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH THE CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) IN 2006, AT THE HEART CENTER IN OTHER COUNTRY. THE PATIENT LIVED AT HOME IN COLOGNE AND WAS SUPPORTED BY A HEART EXCOR TAH-T DRIVER. HIS PRIMARY DRIVER WAS EXCOR S440 AND HIS BACKUP DRIVER WAS EXCOR. IN 2009, THE PATIENT REPORTED TO THE VAD COORDINATORS AT HEART CENTER THAT HIS PRIMARY EXCOR DRIVER WAS EXHIBITING (LOW CARDIAC OUTPUT) ALARMS. THE VAD COORDINATORS ASKED HIM TO COME. IT WAS REPORTED THAT THE PATIENT HAD HEMODYNAMIC PROBLEMS, AND AN AMBULANCE WAS CALLED. THE PATIENT WAS TOO UNSTABLE TO TRANSPORT HIM TO HEART CENTER, SO HE WAS TRANSPORTED TO THE CARDIOWEST TAH-T CENTER, A PERFUSIONIST WHO IS CERTIFIED AND THE HEART EXCOR DRIVER, REPORTED THAT THE PATIENT HAD MASSIVE LUNG EDEMA, LOW SPO2 AND LOW SYSTOLIC BLOOD PRESSURE OF ABOUT 70MMHG. THE PATIENT WAS UNDER ARTIFICIAL RESPIRATION, AND THE EXCOR TAH-T DRIVER CONTINUED TO EXHIBIT E08 ALARMS. PERFUSIONIST REPORTED THAT HE CONNECTED THE EXCOR TAH-T DRIVER TO THE EXCOR LAPTOP AND CONTROLLED THE DRIVER SETTINGS. HE REPORTED THE LAPTOP SHOWED AN INDIFFERENCE OF THE RIGHT AND LEFT CARDIAC OUTPUT (CO) MORE THAN 2 LTR/MIN. THE CO ON LEFT SIDE DECREASED RAPIDLY. FOR DIAGNOSTIC, AN ECHOCARDIOGRAM WAS PERFORMED AND SHOWED NORMAL FILLING IN THE RIGHT ATRIUM AND MAXIMAL FILLED LEFT ATRIUM. AFTER THE PATIENT RECEIVED A CENTRAL VENOUS LINE, THE CENTRAL VENOUS PRESSURE SHOWED ABOUT 12MMHG. IT WAS REPORTED THAT IN THE ECHOCARDIOGRAM, NO FLOW WAS SEEN AFTER THE AORTIC VALVE OF THE TAH-T. THE DOCTORS AT COLOGNE TRIED TO STABILIZE THE PATIENT TO TRANSPORT HIM TO HEART CENTER. A V-A ECMO WAS IMPLANTED WITHOUT SUCCESS. THE PATIENT EXPIRED AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICAL HEART DSQ SYNCARDIA SYSTEMS, INC. TAH-T 63068

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death