BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2010690 · Received February 25, 2011

    Report

    Report Number
    1820334-2011-00094
    Event Type
    Injury
    Date Received
    February 25, 2011
    Report Date
    January 24, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ADDITIONAL SURGICAL PROCEDURES ARE NOT SPECIFICALLY ADDRESSED IN THE IFU. PT NEEDS ADDITIONAL REPAIR BUT THAT HAS NOT BEEN SCHEDULED. ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2008. THE PT RECEIVED A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND TWO ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INCIDENT. ON (B)(6), 2010, THE PT UNDERWENT AN ADDITIONAL PROCEDURE DUE TO THE RESULTS OF A FOLLOW-UP EXAM. THE PT HAD DEVELOPED A TYPE II ENDOLEAK WHICH WAS TREATED BY A GLUING TECHNIQUE UTILIZED AROUND THE INTERIOR MESENTERIC ARTERY. ON (B)(6), 2011, THE AREA REP WAS MADE AWARE OF A FOLLOW-UP THAT DISCOVERED A TYPE IA ENDOLEAK. THE PHYSICIAN PLANS TO TREAT THE LEAK WITH ADDITIONAL DEVICE PLACEMENT (OF ANOTHER MANUFACTURERS). THE PT HAS YET TO UNDERGO THE ADDITIONAL REPAIR. NO IMAGES ARE AVAILABLE TO ASSIST WITH THIS INVESTIGATION.

    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 2155987

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention