BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2140353 · Received June 16, 2011

    Report

    Report Number
    1820334-2011-00331
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    June 2, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION- UNKNOWN AS LOT IS UNKNOWN. SPECIFIC ADDITIONAL PROCEDURE HAS NOT YET BEEN DETERMINED. PATIENT IS BEING FOLLOWED UP BY PHYSICIAN. ENDOLEAKS ARE LABELED IN THE IFU. NO DEVICE OR IMAGES HAVE BEEN PROVIDED TO ASSIST IN THIS INVESTIGATION. 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 (B)(6) 2011. FOLLOW UP REVEALED AN ENDOLEAK OF UNKNOWN TYPE AND THE PATIENT IS SCHEDULED TO UNDERGO ANGIOGRAM TO DETERMINE THE TYPE OF ENDOLEAK AND A COURSE OF ACTION. 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) AND THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR (B)(6) 2011. THE PATIENT RECEIVED A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND TWO ZENITH FLEX ILIAC LEG GRAFTS. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INCIDENT. ON (B)(6), THE COOK AREA REPRESENTATIVE WAS CONTACTED DUE TO THE PATIENT HAVING EITHER A TYPE I OR A TYPE II ENDOLEAK THAT WILL LEAD TO INTERVENTION. ON (B)(6), THE PATIENT IS TO UNDERGO AN ANGIOGRAM TO DETERMINE WHAT TYPE OF ENDOLEAK IS PRESENT AND WHAT TYPE INTERVENTION WILL BE NEEDED.

    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 Other