BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2090888 · Received May 12, 2011

    Report

    Report Number
    1820334-2011-00225
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 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) - PT OUTCOME WAS NOT PROVIDED BY THE RPTR. (B)(4) - MISPLACEMENT IS LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN (B)(6) MALE PT UNDERWENT LEFT COMMON ILIAC ARTERY ANEURYSM (THE DIAMETER WAS 30MM) AND BOTH SIDE OF INTERNAL ILIAC ARTERY ANEURYSM REPAIR. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR THE PROCEDURE. THE PT EXPERIENCED OPEN SURGERY FOR AAA AND HAD LEFT HERNIA INGUINALIS. MOREOVER, ANAMNESIS WAS HYPERPIESIA AND HYPERLIPEMIA. THE PHYSICIAN PLANNED TO PLACE ONE ILIAC LEG FROM BIFURCATION OF LEFT COMMON ILIAC ARTERY, WHICH WAS BLOOD VESSEL PROSTHESIS, TO EXTERNAL ILIAC ARTERY UNDER FLUOROSCOPE. DURING PLACEMENT, THE FLUOROSCOPE STARTED PLAYING BACK THE RECORDED IMAGE, AND THE PHYSICIAN WAS NOT ABLE TO SEE THE ILIAC LEG POSITION. UNDER THE CONDITION, THE ILIAC LEG WAS PLACED. THEN THE TWO PROXIMAL STENTS WERE STUCK OUT INTO AORTA, AND LENGTH OF THE ILIAC LEG TO EXTERNAL ILIAC ARTERY WAS NOT ENOUGH. AN ADDITIONAL ILIAC LEG WAS PLACED TO RESOLVE IT. THE PHYSICIAN DECIDED TO TAKE FOLLOW-UP OBSERVATION SINCE THE PROCEDURE TOOK A LONG TIME UNDER ANESTHESIA. THE PT'S CONDITION AFTER THE PROCEDURE WAS NOT PROVIDED BY THE REPORTER.

    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 F2533300

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR