BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 1381869 · Received May 13, 2009

    Report

    Report Number
    1820334-2009-00250
    Event Type
    Injury
    Date Received
    May 13, 2009
    Date of Event
    April 14, 2009
    Report Date
    April 14, 2009
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVELOPMENT OF THE ZENITH DEVICE SUCCESSFULLY COMPLETED ALL VERIFICATION AND VALIDATION ACTIVITIES SHOWING THE DEVICE MET THE DESIGN REQUIREMENTS AND THAT THE REQUIREMENTS MET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, THE CORRECT DEPLOYMENT PROCEDURE, AND THE PROPER OVERLAP BETWEEN COMPONENTS. IT APPEARS THAT THE ORIGINAL PROCEDURE WAS DONE AS AN EMERGENCY CASE AND THE PHYSICIAN DECIDED TO IMPLANT MAIN BODY EXTENSIONS AND A CONVERTER IN THE PATIENT'S ILIAC ARTERY, BASED ON THE NEEDS OF THE PATIENT AT THAT TIME. HOWEVER, IT SHOULD BE NOTED THESE DEVICES ARE NOT INDICATED FOR ISOLATED ANEURYSMS IN THE ILIAC NOR ARE MAIN BODY EXTENSIONS AND CONVERTERS INTENDED TO BE USED SEPARATE FROM A MAIN BODY DEPLOYMENT. ALTHOUGH THE ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE DETERMINED, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE, UNDERWENT ZENITH PLACEMENT IN 2007. THIS HAD BEEN A LATE NIGHT ILIAC RUPTURE CASE. THE PHYSICIAN HAD STARTED BY PUTTING IN TWO MAIN BODY EXTENSIONS ON THE LEFT TO BUILD DOWN. HE ALSO PLACED A CONVERTER GRAFT AND ANOTHER MAIN BODY EXTENSION. THE PHYSICIAN ALSO PUT TWO LIMBS OF ANOTHER MANUFACTURER DISTAL TO THE CONVERTER. OVER THE PAST TWO YEARS, THE TORTUOUS LEFT ILIAC CAUSED THE CONVERTER TO POP OUT OF THE MAIN BODY EXTENSIONS CAUSING AN ENDOLEAK. THE REP SUGGESTED IMPLANTING A RENU CONVERTER AND BYPASSING EVERYTHING IN THE LEFT ILIAC. THE PHYSICIAN DID THIS, ALSO USING A LEG EXTENSION GRAFT IN THE RIGHT AND AN OCCLUDER ON THE LEFT WHERE THE OTHER MANUFACTURER'S DEVICES WERE. HE THEN PERFORMED A FEMORAL-FEMORAL BYPASS AND EVERYTHING TURNED OUT GREAT. PATIENT IS FINE.

    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 1473995

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention