BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2211311 · Received August 3, 2011

    Report

    Report Number
    1820334-2011-00410
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 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

    (B)(4) - OCCLUSION IS LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PT WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED. THE PHYSICIAN TRIED TO PLACE AN ILIAC LEG GRAFT RIGHT BEFORE THE BIFURCATION OF THE INTERNAL ILIAC ARTERY, BUT THE BIFURCATION BECAME COVERED BY THE ILIAC LEG GRAFT. THE PHYSICIAN TRIED TO PUSH THE DISTAL PART OF THE ILIAC LEG GRAFT UP USING A BALLOON CATHETER TO SOLVE OCCLUSION, BUT FAILED. HE DECIDED TO TAKE A WAIT AND SEE APPROACH AND COMPLETED THE PROCEDURE. THE PT HAD A FAVORABLE OUTCOME 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 F2628926

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability