BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3072625 · Received April 19, 2013

    Report

    Report Number
    2916596-2013-00429
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596-2/24/12-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SUCCESSFULLY TRANSPLANTED WITHOUT ISSUE. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. REPORTS OF DISCONNECTION OF THE BEND RELIEF FROM THE SEALED OUTFLOW GRAFT HAVE BEEN ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM, UPDATED DEVICE LABELING, AN URGENT MEDICAL DEVICE CORRECTION NOTICE (2916596-2/24/12-001-C) AND A SEALED OUTFLOW GRAFT BEND RELIEF COLLAR (SOBR COLLAR) USED TO SECURE THE BEND RELIEF TO THE SEALED OUTFLOW GRAFT AND INCREASE THE ASSEMBLY'S RESISTANCE TO FORCES THAT WOULD TEND TO DISLODGE THE BEND RELIEF. THIS DESIGN MODIFICATION WAS APPROVED IN A PMA SUPPLEMENT AND HAS BEEN IMPLEMENTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). DURING A ROUTINE TRANSPLANT PROCEDURE, THE SURGEON REPORTEDLY NOTED THAT THE BEND RELIEF WAS DISCONNECTED FROM THE OUTFLOW GRAFT AND WAS CREATING A KINK IN THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169187 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 113239

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other