BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2843685 · Received October 26, 2012

    Report

    Report Number
    1820334-2012-00475
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 1, 2012
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    VALVE LEAKED WHILST CLOSED FROM THE VALVE ASSEMBLY AND FROM BEFORE. PT OUTCOME AND ADDITIONAL INFORMATION HAVE NOT BEEN PROVIDED TO ASSIST IN THIS INVESTIGATION BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 3238531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK