BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 2843355 · Received November 19, 2012

    Report

    Report Number
    2916596-2012-01124
    Event Type
    Death
    Date Received
    November 19, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 23, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPIRED ON (B)(6) 2012. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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. APPROXIMATELY 11 DAYS POST-IMPLANT, THE PATIENT BEGAN EXHIBITING HEART FAILURE SYMPTOMS AND WAS READMITTED TO THE ICU. THE PATIENT'S CHEST WAS REOPENED AND THE SURGEON REPORTED THAT THERE WAS NO FLOW THROUGH THE GRAFT. THE PATIENT EXPIRED SHORTLY AFTER. THE VAD COORDINATOR MENTIONED THE POSSIBILITY OF A LOW LEVEL INFECTION, AND THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104912 109147

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death