BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4900877 · Received July 8, 2015

    Report

    Report Number
    2916596-2015-01247
    Event Type
    Death
    Date Received
    July 8, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 10, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED, AND AN AUTOPSY WAS NOT PERFORMED. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED HEMOLYSIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE LISTS HEMOLYSIS AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 2 MONTHS. THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. 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). IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO COMPLICATIONS OF HEART FAILURE AND ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS. A RAMP STUDY WAS PERFORMED ON (B)(6) 2015 WHICH SHOWED THAT THE PUMP WAS UNLOADING THE LEFT VENTRICLE. THE SPEED WAS SET AT 10,000 RPM. THE PATIENT'S SYSTOLIC PULMONARY ARTERY PRESSURE WAS 60 MMHG, MEAN ARTERIAL PRESSURE WAS 73MMHG, AND HEART RATE WAS 115 BPM WITH NO ARRHYTHMIA. THE PATIENT'S LDH LEVELS WERE ELEVATED AND CONTINUED TO RISE TO 1500 U/L. THE PHYSICIAN REVIEWED THE ECHOCARDIOGRAM FROM (B)(6) 2015 AND FELT THAT THE POSITION OF THE PUMP WAS ADEQUATE AND PROPERLY PLACED. X-RAYS WERE TAKEN; HOWEVER, THEY WERE DIFFICULT TO VIEW DUE TO THE PATIENT'S SIZE. THE PATIENT IS CURRENTLY ON LEVOPHED, DOBUTAMINE, AND VASOPRESSIN. FURTHER INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015, DUE TO MULTI-SYSTEM ORGAN FAILURE. THE PATIENT WAS EXPERIENCING HEMOLYSIS WITH LACTATE DEHYDROGENASE LEVELS OF 1400 U/L, DARK URINE, AND DEVELOPED RENAL FAILURE. THE PATIENT WAS ALSO EXPERIENCING ELEVATED POWERS WHILE HOSPITALIZED. THE HOSPITAL STAFF WAS UNABLE TO STATE WHETHER IT WAS A PUMP ISSUE OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443136 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| H| R