BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3841411 · Received May 30, 2014

    Report

    Report Number
    2953200-2014-01089
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    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 STENT GRAFT SYSTEM WAS IMPLANTED FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. THE PATIENT REPORTED A STENT MIGRATION AND SEVERAL ENDOLEAKS. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REPAIR AN UNKNOWN ENDOLEAK. THE PHYSICIAN WAS UNSURE IF IT WAS A TYPE II OR TYPE III ENDOLEAK. ANOTHER MANUFACTURER'S GRAFT WAS USED TO RELINE ONE OF THE PREVIOUSLY PLACED STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318718 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR C04347

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention