BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1922665 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02208
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    August 26, 2009
    Report Date
    August 26, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT WAS SELECTED FOR USE IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE DEVICE PACKAGING WAS OPENED AND A KINK IN THE TIP OF THE DELIVERY CATHETER WAS IDENTIFIED. THE DEVICE WAS NOT USED IN THE PT. THE DEVICE WAS DISCARDED BY THE USER FACILITY. A SECOND DEVICE OF THE SAME SIZE WAS USED TO COMPLETE THE CASE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00176491

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK