BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2903357 · Received January 4, 2013

    Report

    Report Number
    2916596-2012-01298
    Event Type
    Death
    Date Received
    January 4, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 7, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFO PROVIDED TO THE MFR, THE EXPLANTED LVAD WAS DISPOSED OF BY THE HOSPITAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND ALSO REQUIRED AN RVAD FOR RIGHT HEART SUPPORT. THE VAD COORDINATOR REPORTED THE PT WAS REFERRED TO THE DOCTOR FOR A MITRACLIP PROCEDURE FOR SEVERE MITRAL REGURGITATION. THE PT WAS HIGHT RISK FOR SURGERY; THEREFORE, THE PROCEDURE WAS DONE IN THE CATHETERIZATION LAB. THE PT'S ANTERIOR MITRAL LEAFLET WAS RUPTURED DURING THE PROCEDURE AND THE PT WAS TAKEN TO THE OPERATING ROOM (OR) FOR AN EMERGENT REPAIR. THE PT REMAINED CRITICALLY ILL AND EXPIRED FROM PROGRESSIVE HEART FAILURE (HF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5228 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 116755

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death