BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2142298 · Received June 17, 2011

    Report

    Report Number
    1820334-2011-00276
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 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

    ONE (B)(6) 2011, A (B)(6) MALE PATIENT WITH AAA, RENAL DISEASE, PROSTATE CANCER, AND THREE OPEN HEART SURGERIES, UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONDUCTED UNDER GENERAL ANESTHESIA. TYPE II ENDOLEAK WAS CONFIRMED BUT THE PHYSICIAN CONFIRMED IT WAS GONE LATER. ON (B)(6) 2011, THE PATIENT COMPLAINED OF COLDNESS AND EXHAUSTION IN THE RIGHT LEG. A SIMPLE CT SHOWED THE RIGHT ILIAC LEG GRAFT WAS OCCLUDED BECAUSE THE PROXIMAL TIP OF THE LEFT ILIAC LEG GRAFT LEANED TO THE RIGHT SIDE DUE TO ITS KINK AND COVERED THE RIGHT LIMB. IT WAS CONFIRMED BY CT ANGIOGRAPHY AND SOLVED BY PLACING ADDITIONAL BARE STENT. THE PATIENT COULD WALK W/O PROBLEM AND IS DOING FINE AFTER THE PROCEDURE.

    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 F2607173

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention