BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2050885 · Received April 1, 2011

    Report

    Report Number
    2953200-2011-00735
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    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: (GRAFT MIGRATION, ENDOLEAK). RESULTS & CONCLUSIONS: (AORTIC NECK DILATATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM, FOUR YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. CURRENT VESSEL MORPHOLOGY WAS REPORTED AS MODERATE TORTUOSITY, WITH NO CALCIFICATION. IT WAS REPORTED THAT CURRENT FILMS SHOW A MIGRATION WITH A TYPE I ENDOLEAK. THE ANEURYSM HAS INCREASED IN SIZE, DUE TO NECK DILATATION, AND IS NOW 7.6 CM IN DIAMETER. THE TREATMENT PLAN IS TO IMPLANT A CUFF IN THE NEAR FUTURE. NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 1000673

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR