BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA MAIN BODY DELIVERY SYSTEM

    MDR report key: 1060386 · Received June 12, 2008

    Report

    Report Number
    1820334-2008-00310
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 15, 2008
    Report Date
    June 13, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P0820018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE PT UNDERWENT INITIAL AAA REPAIR IN 2004. ONE FLEX MAIN BODY, TWO ILIAC LEG GRAFTS AND ONE LEG EXTENSION GRAFT WERE PLACED. IN 2008, IT WAS NOTED THAT A SECOND PROCEDURE IS NEEDED TO REPAIR AN ENDOLEAK. THE SECOND PROCEDURE HAS NOT BEEN SCHEDULED AT THIS TIME. PT OUTCOME IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA MAIN BODY DELIVERY SYSTEM MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1317238

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention