BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1141071 · Received August 29, 2008

    Report

    Report Number
    1820334-2008-00499
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 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 ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS AND THE CORRECT DEPLOYMENT PROCEDURE. THE DEVICES REMAIN IMPLANTED AND NO IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THE EVENT WAS DUE TO USER ERROR IN THAT THERE WAS INCORRECT PLANNING AND SIZING AS WELL AS PATIENT ANATOMY ISSUES. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. AT THIS TIME, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    A MALE WITH HYPERTENSION AND PREVIOUS PULMONARY COMPLAINTS OF PLEURITIS AND ONE-LUNG DISEASE UNDERWENT AAA REPAIR IN 2008. THE PATIENT'S PREPROCEDURE DIAGNOSIS WAS THAT HIS ANATOMY WAS NOT SUITABLE FOR AAA REPAIR. THE ANGLE OF THE SUPRARENAL ARTERY WAS OVER 60 DEGREES AND THE ILIAC ARTERY WAS SLIGHTLY CALCIFIED. THE PROCEDURE DID PROCEED AS LABELED. ANGIOGRAPHY CONFIRMED PROXIMAL (1820334-2008-00498) AND DISTAL TYPE I ENDOLEAKS. ANOTHER MANUFACTURER'S STENT GRAFT WAS PLACED AT THE PROXIMAL NECK TO SUCCESSFULLY RESOLVE THE LEAK. THE DISTAL ENDOLEAK LESSENED WITH FREQUENT BALLOONING BUT WAS NOT COMPLETELY RESOLVED, SO THE PHYSICIAN DECIDED TO OBSERVE THE LEAK, ANTICIPATING THE LEAK TO DISAPPEAR AFTER NEUTRALIZATION WITH HEPARIN. PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC. NA F2184911

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention