BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANEURX

    MDR report key: 639318 · Received September 20, 2005

    Report

    Report Number
    639318
    Event Type
    Other
    Date Received
    September 20, 2005
    Date of Event
    September 6, 2005
    Report Date
    September 9, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THE GRAFT SEPARATED AT ITS COMPONENTS RESULTING IN BLOOD FILLING THE ANEURYSM. IT WAS PLACED ORIGINALLY TO EXCLUDE AN AAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ENDOVASCULAR GRAFT MIH MEDTRONIC VASCULAR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *