BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2932242 · Received January 25, 2013

    Report

    Report Number
    2916596-2013-00107
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 2 YEARS POST-IMPLANT, THE VAD COORDINATOR REPORTED THAT THE PT WAS READMITTED TO THE HOSPITAL DUE TO RED HEART ALARMS. AN ECHO REVEALED LOW FLOW THROUGH THE PUMP. A DECISION WAS MADE TO EXCHANGE THE PUMP DUE TO SUSPECTED THROMBUS; HOWEVER, ONCE THE CHEST WAS OPENED, THE PUMP WAS OBSERVED TO BE POSITIONED AGAINST THE LATERAL WALL PREVENTING FLOW THROUGH THE DEVICE. THE SURGEON ELECTED TO CONTINUE WITH THE PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36179 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 94251

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention