BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 1675784 · Received May 4, 2010

    Report

    Report Number
    1820334-2010-00193
    Event Type
    Malfunction
    Date Received
    May 4, 2010
    Date of Event
    April 5, 2010
    Report Date
    April 7, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ENDOLEAK IS LISTED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A PATIENT WHOSE RIGHT COMMON ILIAC ARTERY WAS OCCLUDED, UNDERWENT INITIAL AAA REPAIR, AS LABELED, UNDER GENERAL ANESTHESIA. THE PATIENT'S ANATOMICAL FORM WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR BECAUSE OF THE SEVERE PROXIMAL NECK ANGULATION TO BOTH THE AXIS OF THE ANEURYSM AND THE SUPRARENAL AORTA. THE ACCESS ROUTE WAS 5MM. THE PROCEDURE CONSISTED OF PLACEMENT OF A ZENITH MAIN BODY GRAFT, A ZENITH CONVERTER AND A ZENITH ILIAC LEG GRAFT. THE FINAL ANGIOGRAPHY CONFIRMED OCCLUSION OF THE RIGHT RENAL ARTERY (1820334-2010-00194), TYPE III ENDOLEAK FROM THE JUNCTION OF THE CONVERTER AND DISTAL TYPE I ENDOLEAK (1820334-2010-00195). BOTH LEAKS WERE IMPROVED BY BALLOONING, BUT THEY WERE NOT GONE COMPLETELY; ALTHOUGH THE PHYSICIAN EXPECTED THEY WILL BE GONE. THE RIGHT RENAL ARTERY WAS NOT COMPLETELY OCCLUDED BUT THE BLOOD FLOW WAS POOR, THUS THE PHYSICIAN ATTEMPTED CANNULATION USING A GUIDING CATHETER AND A GUIDEWIRE, BUT FAILED, DUE TO A STRONG ANGULATION. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. THE PATIENT'S URINE VOLUME WAS NOT PROBLEMATIC DURING THE PROCEDURE AND THE CREATININE LEVEL WAS 1.8MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2144181

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR