BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2132524 · Received June 8, 2011

    Report

    Report Number
    1820334-2011-00288
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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, FOLLOW-UP GUIDELINES. INITIAL REPAIR PERFORMED IN 2009. THE EXACT DATE IS UNKNOWN. FOLLOW-UP REVEALED ANEURYSM GROWTH DUE TO TYPE IIA ENDOLEAK. THE ENDOLEAK WAS RESOLVED AFTER PLACEMENT OF AN ADDITIONAL ILIAC LEG. ANOTHER ILIAC LEG WAS PLACED ON THE OTHER SIDE AS A PRECAUTIONARY MEASURE. WITHOUT IMAGING OR ADDITIONAL INFORMATION IT IS DIFFICULT TO DETERMINE A ROOT CAUSE OR CONTRIBUTING FACTORS FOR THE REPORTED ENDOLEAK. 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 QUALITY ENGINEERING RISK ASSESSMENT (QERA).

    Description of Event or Problem · 1

    A MALE PATIENT HAD UNDERWENT INITIAL ABDOMINAL AORTIC ANEURYSM REPAIR IN 2009. THE PATIENT RECEIVED A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND TWO ZENITH FLEX AAA ENDOVASCULAR ILIAC GRAFTS. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INCIDENTS. OVER TIME, THE PATIENT'S CT WAS SHOWING ANEURYSM GROWTH. THE PHYSICIAN DETERMINED THAT ONE OF THE CURRENT ZENITH LIMBS IMPLANTED BECAME DISCONNECTED FROM THE MAINBODY GRAFT, SO ON (B)(6) 2011 THE PHYSICIAN PLACED A ZENITH FLEX AAA ENDOVASCULAR ILIAC GRAFT TO BRIDGE THE DISCONNECTED LIMB BACK TO THE BIFURCATED MAIN BODY. THE PHYSICIAN ALSO PLACED A ZENITH FLEX AAA ENDOVASCULAR ILIAC GRAFT ON THE CONTRALATERAL SIDE WITH A ZENITH FLEX AAA ENDOVASCULAR ILIAC GRAFT TO INTACT BETTER SEAL. ANEURYSM WAS DETERMINED REPAIRED AT COMPLETION OF THE SURGERY. ADDITIONAL ZENITH DEVICES WERE PLACED TO RESOLVE THE ENDOLEAK AND CORRECT THE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH COOK, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Required Intervention