BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX

    MDR report key: 3884876 · Received June 19, 2014

    Report

    Report Number
    2953200-2014-01231
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW UP SCAN, ANEURYSM ENLARGEMENT WAS OBSERVED WITH 1CM OF DISTAL MIGRATION. THE GRAFT CURRENTLY SITS AT THE DISTAL END OF THE AORTIC NECK. NO CONTRAST IS EVIDENT IN THE ANEURYSM SAC SO A TYPE I ENDOLEAK CANNOT BE CONFIRMED. THE PHYSICIAN STATES THE POSSIBLE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. NO INTERVENTION IS SCHEDULED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360211 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR M03D551981

    Patients

    Seq Age Sex Outcome Treatment
    1