BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1911041 · Received November 24, 2010

    Report

    Report Number
    2953200-2010-02347
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (RESULTS, CONCLUSIONS) - OTHER: (LACK OF INFO).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 8 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT OR AT THE TIME OF THE EVENT WERE NOT REPORTED. THERE IS A PATENT IMA AND LUMBARS. THE PATIENT WAS FOUND TO HAVE A SUSPECTED TYPE III ENDOLEAK (FABRIC) OR A TYPE II ENDOLEAK AT A RECENT F/U. A SECONDARY INTERVENTION WAS PERFORMED 5 DAYS AFTER THE SUSPECTED ENDOLEAK WAS FOUND; HOWEVER, NO TYPE III ENDOLEAK WAS IDENTIFIED; A KINK OF THE STENT, ABOUT TWO STENT RINGS BELOW THE DISTAL END OF THE GATE, WAS IDENTIFIED IN THE 15X115 LIMB. A 16MM X 135MM ANEURX LIMB WAS USED TO RELINE THE CONTRALATERAL LIMB SUCCESSFULLY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA M02C552114

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention