BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2033892 · Received March 18, 2011

    Report

    Report Number
    1820334-2011-00127
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 15, 2011
    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

    OCCLUSION IS LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) YEAR OLD MALE PATIENT UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE. AFTER PLACEMENT OF A MAIN BODY AND TWO ILIAC LEGS, THE FINAL ANGIOGRAPHY CONFIRMED A DISTAL TYPE I ENDOLEAK FROM THE LEFT. ADDITIONAL LEG GRAFT WAS PLACED TO SOLVE THE LEAK BUT IT COVERED THE INTERNAL ILIAC ARTERY. THE PHYSICIAN COMMENTED THAT THERE WAS ENOUGH LENGTH BUT THE INTERNAL ILIAC ARTERY BIFURCATION POSITION CHANGED DUE TO SLIGHT VESSEL SHAPE CHANGE DUE TO INSERTION OF THE DELIVERY SYSTEM. THE PATIENT IS DOING FINE AFTER THE PROCEDURE AND WILL BE FOLLOWED CLOSELY.

    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 F2537777

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other