BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEMHEART VENO-VENOUS CANNULA (PROTEKDUO)

    MDR report key: 4404498 · Received January 5, 2015

    Report

    Report Number
    2531527-2014-00006
    Event Type
    Injury
    Date Received
    January 5, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 9, 2014
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    DWF
    PMA / PMN Number
    K140999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH A HISTORY OF BIVENTRICULAR FAILURE WAS IMPLANTED WITH A HEARTWARE LVAD, BUT WAS UNABLE TO MAINTAIN FLOW DUE TO CARDIOPULMONARY FAILURE INVOLVING THE RIGHT VENTRICLE. THE PROTEK DUO WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN USING A 0.035 LUNDERQUIST GUIDEWIRE UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHIC AND FLUOROSCOPIC GUIDANCE. POSITION WAS VERIFIED BY ANESTHESIA. PT WAS WEANED FROM BYPASS AND CHEST WAS BEING CLOSED WHEN THE PT'S BLOOD PRESSURE BEGAN TO DROP. BLEEDING WAS NOTED, THE CHEST WAS REOPENED, AND HE WAS PLACED BACK ON BYPASS. DR (B)(6) NOTED THE PT HAD A FRIABLE PULMONARY ARTERY WHICH HAD DISSECTED NEAR THE RIGHT VENTRICULAR OUTFLOW TRACT. DR (B)(6) ALSO NOTED THAT PROTEK DUO CANNULA MIGRATION MOST LIKELY OCCURRED DURING WEANING FROM BYPASS WHEN THE VENTRICLES FILLED TO CAPACITY AND WERE CONDUCTING/CONTRACTING ON THEIR OWN. THE PULMONARY ARTERY WAS SURGICALLY REPAIRED, THE PROTECK DUO WAS REMOVED, AND ECMO CANNULAS WERE IMPLANTED IN ORDER TO CONTINUE CARDIOPULMONARY SUPPORT. THE PT, AT LAST REPORTED 14 DAYS FOLLOWING THE PROCEDURE, HAD BEEN SUCCESSFULLY WEANED OFF OF TEMPORARY SUPPORT AND WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3093 TANDEMHEART VENO-VENOUS CANNULA (PROTEKDUO) VENO-VENOUS CANNULA DWF CARDIAC ASSIST, INC. 5140-4629 AM047238

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention HEARTWARE LVAD