BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1962667 · Received January 10, 2011

    Report

    Report Number
    1820334-2011-00020
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MIGRATION IS ADDRESSED IN THE IFU. THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES, F/U GUIDELINES. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION. MIGRATION OF A ZENITH DEVICE IMPLANTED IN 2008 DUE TO PT ANATOMY (FLARED PROXIMAL NECK). INADEQUATE PROXIMAL FIXATION LIKELY RESULTED IN THE LATE MIGRATION. THE EVENT WAS RESOLVED WITH THE PLACEMENT OF A ZENITH MAIN BODY EXTENSION. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN MIGRATION. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QERA (QUALITY ENGINEERING RISK ASSESSMENT).

    Description of Event or Problem · 1

    A MALE PT UNDERWENT ORIGINAL AAA REPAIR IN 2008. NO INFO WAS PROVIDED REGARDING THE DEVICES IMPLANTED. ON (B)(6) 2010, THE PT UNDERWENT A SECONDARY PROCEDURE TO TREAT MIGRATION DUE TO A FLARED NECK. THE MAIN BODY WAS A 30 MM DIAMETER GRAFT; THEREFORE, TREATED WITH A 30 MM ZENITH MAIN BODY EXTENSION. THE DEVICE WAS PLACED PER THE INSTRUCTIONS FOR USE AND THE RESULT WAS SUCCESSFUL. NO ENDOLEAK WAS PRESENT FOLLOWING PLACEMENT.

    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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention