BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2040829 · Received March 31, 2011

    Report

    Report Number
    2916596-2011-00126
    Event Type
    Death
    Date Received
    March 31, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS UNABLE TO CONDUCT AN INVESTIGATION OF THE DEVICE BECAUSE IT WAS NOT EXPLANTED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. BASED ON THE INFO AVAILABLE AND DUE TO THE DEVICE NOT BEING RETURNED FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THERE WERE PUMP STOP INDICATIONS, LOW FLOW AND HIGH POWER READINGS. THE SYSTEM CONTROLLER WAS SWAPPED WITH ANOTHER SYSTEM CONTROLLER BUT THE PUMP DID NOT RETURN TO NORMAL. HEPARIN WAS ADMINISTERED AND THE PUMP SPEED WAS INCREASED TO TREAT FOR POTENTIAL THROMBUS. A CATHETER WAS INSERTED INTO THE LEFT VENTRICLE TO ADMINISTER TPA DIRECTLY TO THE PUMP. THE PT UNFORTUNATELY EXPIRED AFTER TPA WAS ADMINISTERED. THE MFR WAS ADVISED THAT THE PUMP WOULD NOT BE EXPLANTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death