BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2220526 · Received July 18, 2011

    Report

    Report Number
    1820334-2011-00385
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) MALE PT UNDERWENT AAA REPAIR UNDER GENERAL ANESTHESIA. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONSISTED OF PLACEMENT OF A MAIN BODY AND TWO ILIAC LEG GRAFTS. THE FINAL CONFIRMATORY ANGIOGRAPHY SHOWED ENDOLEAK SUSPECTED OF TYPE II OR TYPE III FROM THE JUNCTION ON THE RIGHT SIDE. THE PHYSICIAN ULTIMATELY DETERMINED THE LEAK WAS TYPE IV BECAUSE ANOTHER ANGIOGRAPHY INSIDE THE GRAFT SHOWED LUMBER ARTERY. THE PHYSICIAN DECIDED TO TAKE A WAIT AND SEE APPROACH AND COMPLETED THE PROCEDURE. ACT 20 MINUTES BEFORE COMPLETION OF THE PROCEDURE WAS 517. THE PT'S CONDITION IS UNK AS NOT PROVIDED BY 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 F2643459

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR