BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3760673 · Received April 7, 2014

    Report

    Report Number
    2916596-2014-00532
    Event Type
    Death
    Date Received
    April 7, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS ADVISED THAT THE LVAD PUMP WILL NOT BE RETURNING FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). INFORMATION WAS PROVIDED TO THE MANUFACTURER THROUGH THEIR DEVICE TRACKING SYSTEM INDICATING THAT THE PATIENT EXPIRED AND THE CAUSE OF DEATH IS NOTED AS "CLOT." ADDITIONAL INFORMATION PROVIDED INDICATES THAT GOING INTO THE OPERATING ROOM, THE PATIENT HAD CREATINE LEVEL OF 3.3. THE PATIENT HAD SUBSTANTIAL AMOUNT OF BLEEDING IN ICU AFTER IMPLANT AND RECEIVED MULTIPLE DOSES OF FIBA. BLEEDING CONTINUED AND THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR). UPON REOPENING THE CHEST, A CLOT WAS VISUALIZED IN THE LEFT VENTRICLE AND THE AORTA. PULMONARY ARTERY LINE WAS DISLODGED AND CARDIAC MESSAGE WAS STARTED. THE PATIENT EXPIRED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205561 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 137626

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death