BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3032465 · Received March 29, 2013

    Report

    Report Number
    2916596-2013-00340
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596-2/24/12-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS OF DISCONNECTION OF THE BEND RELIEF FROM THE SEALED OUTFLOW GRAFT HAVE BEEN ADDRESSED THROUGH THE MFR'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. THE DEVICE WAS RETURNED TO THE MFR AND IS CURRENTLY BEING ANALYZED. 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE SURGEON THAT THE PT HAS A PLATELET DISORDER, AND MOST RECENTLY THE PT HAD BEEN SUFFERING FROM HEMOLYSIS AND ELEVATED LDH LEVELS. THE SURGEON DECIDED TO EXCHANGE THE PT'S PUMP DUE TO SUSPECTED THROMBUS. UPON OPENING THE PT'S CHEST, THE SURGEON NOTED THAT THE PT'S OUTFLOW GRAFT BEND RELIEF HAD BECOME DISENGAGED. UPON CLOSER INSPECTION IT WAS NOTED THAT THE BEND RELIEF HAD CAUSED GRAFT EROSION AND THERE WAS A VISIBLE CLOT ON THE OUTFLOW GRAFT. THE LVAD WAS EXCHANGED WITH A NEW LVAD OUTFLOW GRAFT AND THE SEALED OUTFLOW GRAFT BEND RELIEF WAS SECURED WITH THE NEW SEALED OUTFLOW GRAFT BEND RELIEF COLLAR. THE PT REMAINS ONGOING WITH THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129970 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 108441

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention