BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1233243 · Received November 11, 2008

    Report

    Report Number
    1820334-2008-00654
    Event Type
    Death
    Date Received
    November 11, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    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 OCCLUSIN OF THE RENAL OR INTERNAL ILIAC ARTERIES. THE DEVICE REMAINS IMPLANTED AND NO IMAGES WERE PROVIDE TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THE EVENT WAS DUE TO USER ERROR DURING DEPLOYMENT AND INCORRECT PLANNING AND SIZING. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DURING AAA REPAIR IN 2008, THE SUPRARENAL STENT GOT SNAGGED BY THE TOP CAP, AND INVOLUTED PARTIALLY INTO THE FABRIC-COVERED PORTION OF GRAFT. THE PHYSICIAN PARTIALLY INFLATED A BALLOON TO TRY TO PUSH THE STENT UPWARD BUT WAS UNSUCCESSFUL. SUBSEQUENT ANGIOGRAM REVEALED NO ENDOLEAK SO THE PHYSICIAN DETERMINED TO LEAVE THE GRAFT AS IT WAS. THE RIGHT HYPOGASTRIC WAS ALSO COVERED UNINTENTIONALLY DUE TO TORTUOSITY RESTRICTING MANEUVERABILITY OF THE DEVICE. WITHIN 24 HOURS, THE PATIENT HAD EXPIRED DUE TO MI. THE CAUSE WAS DETERMINED TO BE UNRELATED TO THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A 2101071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death