BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT

    MDR report key: 1000478 · Received February 21, 2008

    Report

    Report Number
    1820334-2008-00100
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE PATIENT HAD INITIAL AAA REPAIR IN 2007. ONE FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. THE MAIN BODY WAS INADVERTENTLY PLACED LOW, BUT DID NOT IMMEDIATELY SHOW AN ENDOLEAK. THE FIRST CT SHOWED A TYPE I ENDOLEAK. THE PHYSICIAN DECIDED TO USE A MAIN BODY EXTENSION GRAFT IN 2008, TO ADDRESS THE ENDOLEAK AS THE PATIENT HAD A RENAL STENT THAT EXTENDED AT LEAST 5MM INTO THE LUMEN OF THE AORTA. A VERY SLIGHT TYPE I ENDOLEAK PRESENTED POST EXTENSION PLACEMENT, BUT THE PHYSICIAN FELT AS THOUGH IT WOULD CEASE, ONCE THE ACT RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT MIH ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1832731

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention