BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3122547 · Received May 16, 2013

    Report

    Report Number
    2017233-2013-00312
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT / SERIAL NUMBER IS UNKNOWN. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE COMPLETED. FURTHER INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    IN (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(4) 2013, THE GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM DEVICE MIGRATED 12 MM DISTAL FROM THE LEFT RENAL ARTERY. IT WAS ALSO REPORTED, THE RIGHT INTERNAL ARTERY IS PATENT AND THE PATIENT HAS A TYPE II ENDOLEAK. THE PHYSICIAN IS MONITORING THE PATIENT. NO FURTHER ADVERSE EVENTS WERE REPORTED. FURTHER INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217921 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O