BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCUALR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1233848 · Received November 12, 2008

    Report

    Report Number
    1820334-2008-00648
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 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. SPECIFICALLY, THE IFU STATES THAT KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVERE PROXIMAL NECK ANGULATION, SHORT PROXIMAL AORTIC NECK, AN INVERTED FUNNEL SHAPE, AND CIRCUMFERENTIAL THROMBUS AND/OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. IRREGULAR CALCIFICATION AND/OR PLAQUE MAY COMPROMISE THE FIXATION AND SEALING OF THE IMPLANTATION SITES. NECK'S EXHIBITING THESE KEY ANATOMICAL ELEMENTS MAY BE MORE CONDUCIVE TO GRAFT MIGRATION. 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 DUE TO OFF LABEL USE AND PATIENT ANATOMY. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE WITH ISCHEMIC HEART DISEASE AND A PREVIOUS HISTORY OF HYPERTENSION, STOMACH CANCER HAD ABDOMINAL ARTERIAL ANEURYSM AND COMMON ILIAC ARTERIAL ANEURYSM. THE PATIENT WAS NOT CONSIDERED TO HAVE A SUITABLE FORM FOR ENDOVASCULAR REPAIR BECAUSE THE PROXIMAL NECK WAS 90 DEGREES. HOWEVER, THE PROCEDURE WENT AS LABELED IN 2008. THE PHYSICIAN PLACED A MAIN BODY AND TWO ILIAC LEG GRAFTS BUT PLACED AN ADDITIONAL ILIAC LEG GRAFT TO EXTEND INTO THE CONTRALATERAL EXTERNAL ILIAC ARTERY. FINAL ANGIO REVEALED THERE WAS AN ENDOLEAK. THE PHYSICIAN CONSIDERED IT A TYPE IV ENDOLEAK AND DECIDED TO TAKE A WAIT-AND-SEE APPROACH. PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCUALR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA F2214283

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention