BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4172048 · Received October 10, 2014

    Report

    Report Number
    2916596-2014-01778
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED AT (B)(6). THE PATIENT REMAINS ON LVAD SUPPORT WITH THE PUMP. 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 9 MONTHS POST-IMPLANT, IT WAS REPORTED THAT WHILE IN THE HOSPITAL THE PATIENT HAD PUMP POCKET BLEEDING WHICH REQUIRED 4 UNITS OF RED BLOOD CELLS (RBC). THE PATIENT'S INR WAS 2.8 IU, THE ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) WAS UNKNOWN, AND HIS PLATELET COUNT (PLT) WAS 6268000/UL. AT THE TIME OF THE EVENT, THE PATIENT'S ANTICOAGULATION REGIMEN INCLUDED WARFARIN AND ASPIRIN. THE PATIENT HAD RE-OPERATIVE SURGERY AND THE CAUSE OF THE BLEEDING WAS REPORTED TO BE RELATED TO THE SURGICAL IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643291 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911JPN 137788

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention