BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST (VAD) SYSTEM

    MDR report key: 2092639 · Received May 10, 2011

    Report

    Report Number
    2916596-2011-00185
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 13, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO CONFIRM THE REPORTED EVENT OF DECANNULATION AS THE HOSPITAL STAFF DISPOSED OF THE DEVICE; THEREFORE IT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH BIVENTRICULAR SUPPORT. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT'S RIGHT VENTRICULAR ASSIST DEVICE (PVAD RVAD) CANNULA BECAME DECANNULATED. THE PT WAS TAKEN TO THE OPERATING ROOM AND THE PVAD RVAD AND CANNULA WERE EXCHANGED. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST (VAD) SYSTEM VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 14086-2550-000 72369

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention