BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH RENU CONVERTER AAA ANCILLARY GRAFT

    MDR report key: 1000475 · Received February 21, 2008

    Report

    Report Number
    1820334-2008-00108
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 15, 2006
    Report Date
    January 25, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: STILL UNDER INVESTIGATION

    Description of Event or Problem · 1

    A FEMALE UNDERWENT AAA REPAIR IN 2006. A ZENITH RENU CUFF AND A MAIN BODY EXTENSION WERE PLACED. THE CORE LAB INTERPRETATION OF THE 30-DAY POST-PROCEDURE CT SCAN NOTED A TYPE III ENDOLEAK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU CONVERTER AAA ANCILLARY GRAFT MIH ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1550058

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention