BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 1033834 · Received April 25, 2008

    Report

    Report Number
    3003761017-2008-00015
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 24, 2008
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CSS CONSOLE WAS INDEPENDENTLY EVALUATED BY TWO BIOMEDICAL ENGINEERS. IT WAS REPORTED THAT THE CSS CONSOLE SUCCESSFULLY PASSED CALIBRATION, WAS CONNECTED TO A MOCK TANK, AND PERFORMED AS INTENDED, PUMPING BOTH THE LEFT AND RIGHT SIDES. THE INCIDENT WAS UNABLE TO BE DUPLICATED. THE PRIMARY CONTROLLER FOR THE CSS CONSOLE WILL BE RETURNED TO SYNCARDIA FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PT HAD MARFAN'S SYNDROME, A GENETIC DISORDER CHARACTERIZED BY A PREDISPOSITION TO CARDIOVASCULAR TISSUE ABNORMALITIES. A FEW DAYS PRIOR TO THE IMPLANT OF THE CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T), THE PT HAD UNDERGONE A "FROZEN ELEPHANT TRUNK" SURGICAL PROCEDURE TO REPLACE A LARGE PORTION OF THE DEFECTIVE AORTA. IT WAS REPORTED THAT DURING THE AORTIC SURGERY, THE PT'S HEART HAD STOPPED FOR APPROX ONE MINUTE BEFORE BEING RESTARTED. AFTER A DAY OR TWO, THE AORTIC VALVE BECAME OCCLUDED BY A CLOT THAT EXTENDED FROM THE VENTRICLE TO THE AORTIC ROOT, AND THE PT WAS SCHEDULED FOR TAH-T SURGERY. CUSTOMER REPORTED THAT THE PT WAS NOT CONSCIOUS PRIOR TO THE IMPLANT OF THE TAH-T. A SUCCESSFUL CALIBRATION OF THE CIRCULATORY SUPPORT SYS (CSS) CONSOLE HAD BEEN COMPLETED PRIOR TO TAH-T SURGERY, AND THE CONSOLE WAS FUNCTIONING AS INTENDED. DURING THE IMPLANTATION PROCEDURE, CUSTOMER REPORTEDLY DID NOT PERFORM THE CUSTOMARY LEAK TEST BECAUSE OF THE RISK OF ATRIAL TISSUE RUPTURE BECAUSE OF THE PT'S MARFAN'S SYNDROME. DURING THE TAH-T IMPLANT SURGERY, THE CUSTOMER REPORTED THAT, AT TIME OF DE-AIRING, THE PRIMARY CONTROLLER DID NOT APPEAR TO PUMP THE LEFT SIDE OF THE TAH-T. WHEN THE CSS CONSOLE WAS SWITCHED TO THE BACKUP CONTROLLER, THE LEFT SIDE APPEARED TO PUMP PROPERLY. THE RIGHT VENTRICLE WAS ALLOWED TO PUMP TO ALLOW FILLING OF THE LEFT VENTRICLE FOR DE-AIRING. CUSTOMER REPORTED THAT THE LEFT ATRIUM RUPTURED EARLY DURING RIGHT SIDE PUMPING. THE LEFT ATRIUM WAS REPAIRED, BUT IT IS NOT CLEAR WHETHER THE EVENT WAS RELATED TO THE DEVICE OR TO THE PT'S MARFAN'S SYNDROME. AFTER SURGERY THE PT WAS SWITCHED TO ANOTHER CSS CONSOLE. THE PT REMAINS IN THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE DSQ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 22

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention