BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6091799 · Received November 9, 2016

    Report

    Report Number
    2916596-2016-02186
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 14, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 11 MONTHS. THE PUMP WAS NOT RETURNED FOR EVALUATION AS IT WAS RETAINED BY THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED DRIVELINE INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTIONS ARE LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING STERILIZATION AND PACKAGING DOCUMENTATION, FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT PRESENTED WITH NAUSEA AND VOMITING WITH NO VISIBLE INFECTION, AND THAT ON (B)(6) 2016, THE PATIENT DEVELOPED A VISIBLE AND SEVERE INFECTION AT THE DRIVELINE EXIT SITE. IT WAS REPORTED THAT TRAUMA TO THE DRIVELINE EXIT SITE WAS SUSPECTED. THE PATIENT¿S WHITE BLOOD CELL COUNT WAS ELEVATED. THE SOURCE WAS (B)(6). IT WAS REPORTED THAT THE DRIVELINE INFECTION TRACKED TO THE LVAD PUMP POCKET. DRAINAGE WAS COMING OUT OF THE BEND RELIEF OF THE DRIVELINE, AND THE PUMP POCKET AND STERNUM WERE REPORTEDLY INFECTED. A SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE LVAD, AND IMPLANT AN EXTRACORPOREAL MECHANICAL CIRCULATORY SUPPORT DEVICE FOR LEFT HEART SUPPORT. IT WAS REPORTED THAT THE PATIENT THEN SUFFERED RIGHT HEART FAILURE AND REQUIRED MECHANICAL CIRCULATORY SUPPORT FOR THE RIGHT HEART. THE PATIENT¿S CONDITION CONTINUED TO WORSEN DESPITE MAXIMUM SUPPORT. THE PATIENT EXPIRED THE EVENING OF (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742123 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106015

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R