BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3232246 · Received July 8, 2013

    Report

    Report Number
    1820334-2013-00265
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, AN (B)(6) OLD FEMALE PT UNDERWENT AAA REPAIR. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR BUT HIGH CALCIFICATION WAS OBSERVED. THE PHYSICIAN INSERTED THE DELIVERY SYSTEM FROM THE RIGHT FEMORAL BUT WOULD NOT ADVANCE TO THE TARGET SITE. HE REMOVED IT WITH A BACKUP AND THE REPLACEMENT WAS ADVANCED WITHOUT PROBLEM AND THE MAIN BODY WAS PLACED. HOWEVER, HE CONFIRMED DAMAGE IN THE RIGHT EXTERNAL ILIAC ARTERY TO THE RIGHT FEMORAL ARTERY. AFTER PLACING A ILIAC LEG GRAFT ON EACH ILIAC LEG GRAFT ON EACH ILIAC ARTERY, THE DAMAGED VESSEL WAS REPLACED WITH AN ARTIFICIAL VESSEL IN CONSIDERATION OF THE VESSEL CONDITION DUE TO HER AGE AND CALCIFICATION. THE PT IS DOING FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310293 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 3929778

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention