BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3233053 · Received July 11, 2013

    Report

    Report Number
    2916596-2013-00884
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 14, 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
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS PERFORMED AND THE PT REMAINS ONGOING ON LVAD SUPPORT. THE USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM THE (B)(6). 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 INFO 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 (LVAD). THE MANUFACTURER RECEIVED USER FACILITY REPORT # (B)(4) FROM THE (B)(6) WHICH STATED RADIOLOGIC STUDIES DEMONSTRATED A DISCONNECTION OF THE BEND RELIEF FROM THE SEALED OUTFLOW GRAFT. THE PT WAS ADMITTED FOR OPERATIVE REPAIR OF THE DISCONNECT. THE PROCEDURE WAS PERFORMED BY IMPLANTATION OF A SEALED OUTFLOW GRAFT BEND RELIEF COLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320488 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 112483

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention