BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1922879 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02210
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    December 9, 2008
    Report Date
    December 9, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX AORTIC EXTENDER CUFF WAS SELECTED FOR USE IN AN ABDOMINAL AORTIC ANEURYSM PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS KINKED WHEN IT WAS REMOVED FROM THE BOX. THE DEVICE WAS NOT USED IN THE PT AND ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE CASE. THE PT IS FINE. THE DEVICE WAS DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00176483

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK