BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 4163158 · Received October 10, 2014

    Report

    Report Number
    2916596-2014-01723
    Event Type
    Death
    Date Received
    October 10, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 15, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXCHANGED PUMP FOR ANALYSIS. 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). APPROXIMATELY 4 YEARS POST-IMPLANT, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SEPSIS ((B)(6)) AND THE PATIENT'S LACTATE DEHYDROGENASE (LDH) LEVELS WERE 300 IU/L. ON (B)(6)2014, THE PATIENT HAD A TOOTH EXTRACTION; THEREFORE, ORAL ANTICOAGULATION WAS STOPPED AND THE PATIENT WAS PUT ON HEPARIN. AN UNKNOWN AMOUNT OF TIME LATER, THE PATIENT'S HEALTH STARTED TO DETERIORATE. ON (B)(6) 2014, THE PATIENT BECAME INOTROPE DEPENDANT AND HAD INCREASED LIVER ENZYMES. IN ADDITION, THE PATIENT'S LEFT VENTRICLE HAD INCREASED IN DIMENSION AND THE AORTIC VALVE WAS OPENING WITH EVERY BEAT. ADDITIONALLY, THE PATIENT'S LDH WAS ELEVATED AND HE EXPERIENCED SHORTNESS OF BREATH. THE HOSPITAL SUSPECTED PUMP THROMBUS AND A DECISION WAS MADE TO EXCHANGE THE PUMP ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPIRED ON (B)(6)2014 AND THE REPORTED CAUSE OF DEATH WAS SEPSIS. THE SURGEON REPORTED THAT THE SEPSIS WAS RELATED TO THE (B)(6) THAT THE PATIENT HAD IN HIS BLOOD STREAM DURING THE PUMP EXCHANGE. IN ADDITION, DURING THE PUMP EXCHANGE, THE PATIENT LOST VASCULAR RESISTANCE AND REQUIRED ADMINISTRATION OF VASOPRESSORS FOR HEMODYNAMIC SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643653 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103693 92376

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death