BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCUALR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 1233847 · Received November 12, 2008

    Report

    Report Number
    1820334-2008-00638
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    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

    EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU SPECIFICALLY CAUTIONS THAT INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. THE DEVICE REMAINS IMPLANTED AND NO IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THE EVENT WAS DUE TO USER ERROR AND INCORRECT PLANNING AND SIZING. WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE PATIENT WITH A STENOSED RIGHT EXTERNAL ILIAC ARTERY AND COMPLETE OCCLUSION OF THE LEFT EXTERNAL ILIAC ARTERY UNDERWENT AAA REPAIR IN 2008. PTA FOR THE COMPLETE OCCLUDED AREA OF THE LEFT EXTERNAL ILIAC ARTERY WAS TRIED, BUT THE WIRE WOULD NOT GO THROUGH. THE TREATMENT PLAN WAS CHANGED TO USE A CONVERTER GRAFT. THE PROCEDURE WENT AS LABELED. CONFIRMATORY ANGIOGRAPHY CONFIRMED A TYPE III ENDOLEAK FROM A GAP BETWEEN THE MAIN BODY AND THE CONVERTER. AFTER BALLOONING WITH ANOTHER MANUFACTURER'S BALLOON, A MINOR LEAK WAS STILL EVIDENT. HOWEVER, IT WAS DECIDED THAT THE PATIENT WOULD BE UNDER OBSERVATION SINCE THE FORMING OF A BLOOD CLOT BY NEUTRALIZATION OF HEPARIN WAS EXPECTED. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCUALR GRAFT AAA ANCILLARY COMPONENT CONVERTER NONE MIH COOK, INC. NA F2193619

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention