BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2030366 · Received March 21, 2011

    Report

    Report Number
    1820334-2011-00145
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO PT INJURY RESULTED IN THIS EVENT, VALVE LEAKS ARE NOT SPECIFICALLY LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE CAPTOR VALVE WAS LEAKING BLOOD ON THE FLEX MAIN BODY (1820334-2011-00144) AND ONE OF THE ILIAC LEG GRAFTS (1820334-2011-00145). NO HARM TO THE PT REPORTED. THE GRAFT WAS SUCCESSFULLY DEPLOYED. BLOOD LOSS WAS NOT EXCESSIVE ENOUGH TO REQUIRE TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA 2601333X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK