BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3042190 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00380
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS SUCCESSFULLY EXCHANGED AND THE PT REMAINS ONGOING ON LVAD SUPPORT. NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED PUMP WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PERFUSIONIST REPORTED THAT AFTER 22 MONTHS OF SUPPORT ON THE LVAD, THE PT HAS SIGNIFICANT AORTIC INSUFFICIENCY AND BEGAN TO HAVE HEMOLYSIS. ANTICOAGULATION MEDICATION WAS ADMINISTERED AND THE PT APPEARED STABLE. THE HOSP SUBSEQUENTLY MADE A DECISION TO EXCHANGE THE LVAD DUE TO CONTINUING HEMOLYSIS AND SUSPICION OF THROMBUS IN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139327 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 102825

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention