BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2140351 · Received June 16, 2011

    Report

    Report Number
    1820334-2011-00357
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    June 9, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - CLAUDICATION IS LABELED IN THE IFU. STENT DISCONNECTING FROM GRAFT IS NOT LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE PATIENT UNDERWENT INITIAL ENDOVASCULAR AORTIC REPAIR ON (B)(6), 2004. DURING FOLLOW-UP, A COMPLETE DISCONNECT OF GRAFT FROM SUPRARENAL STENT WAS OBSERVED AND THE GRAFT HAD FALLEN DOWN INTO THE SAC. INFORMATION WAS PROVIDED TO THE SALES REP THAT THE PATIENT HAD COME ANNUALLY FOR FOLLOW-UP. A REVIEW OF THE 2010 IMAGING INDICATES IT CLEARLY HAD SOME BREAKS AT THAT POINT, BUT HAD GONE UNREPORTED BY THE RADIOLOGIST READING THE SCAN. THE SUPRARENAL STENT APPEARED TO HAVE SUTURE BREAKS AND THE GRAFT WAS DISCONNECTING FROM THE STENT ON THE LEFT SIDE OF THE AORTIC NECK, STILL APPOSED AND HAD NOT DROPPED AT THIS TIME. THE PATIENT PRESENTED WITH BUTTOCK/LEG CLAUDICATION AND HIS FOLLOW UP 2011 SCAN REVEALED A COMPLETE DISCONNECT. THE PATIENT WILL BE BROUGHT BACK TO THE OPERATING ROOM FOR POSSIBLE SECONDARY INTERVENTION. THE PHYSICIAN WILL SEE IF THEY CAN GET STIFF WIRE ACCESS AND STRAIGHTEN THE GRAFT IN AN EFFORT TO REALIGN AND COVER THE EXPOSED SEGMENT. MIGRATED GRAFT, BUTTOCK/LEG CLAUDICATION, MINIMAL PEDAL PULSES.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other