BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3202072 · Received June 27, 2013

    Report

    Report Number
    2916596-2013-00816
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 31, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596-2/24/12-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS PERFORMED AND THE PATIENT REMAINS ONGOING ON LVAD SUPPORT. THE ATTACHED USER FACILITY REPORT NUMBER: (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY. 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. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED A USER FACILITY REPORT FROM THE (B)(6) REGISTRY STATING THAT X-RAY IMAGES DEMONSTRATED A DISCONNECTION OF THE OUTFLOW GRAFT ATTACHMENT. THE PATIENT WAS ADMITTED AND A SEALED OUTFLOW GRAFT BEND RELIEF COLLAR WAS PLACED TO REPAIR THE DISCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293025 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DSQ THORATEC CORP. 104911 105452

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention