BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1910279 · Received November 23, 2010

    Report

    Report Number
    1820334-2010-00583
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 25, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE 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, F/U GUIDELINES, THE IMPORTANCE OF AN ACCURATE DEPLOYMENT. A TYPE 1B ENDOLEAK WAS RESOLVED BY PLACEMENT OF AN ADD'L ZENITH ILIAC LEG GRAFT. AN ENDOLEAK AT THE LEFT LIMB OF THE MAIN BODY WAS UNSUCCESSFULLY TREATED BY PLACEMENT OF ANOTHER MFR'S STENT. CLASSIFICATION OF THE ENDOLEAK WAS INCONCLUSIVE. PHYSICIAN THOUGHT THE ENDOLEAK WAS A TYPE 2 OR 4 ENDOLEAK, AND DECIDED TO TAKE A WAIT-AND-SEE APPROACH. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN THE REPORTED ENDOLEAKS. WITHOUT IMAGING OR ANATOMICAL DETERMINANTS WE ARE UNABLE TO COMMENT ON THE PATIENT'S SUITABILITY FOR EVAR. IDENTIFICATION OF CONTRIBUTING FACTORS WITH THE INFO PROVIDED IS SPECULATIVE AT THIS TIME. AS WITH ALL ENDOLEAKS, IT IS IMPORTANT THAT THE TREATING PHYSICIAN FOLLOW THE PT'S ENDOLEAK APPROPRIATELY, AND PROVIDE FURTHER TREATMENT IF THE PHYSICIAN FEELS THE PATIENT IS AT RISK OF ONGOING SAC PRESSURIZATION, ANEURYSM GROWTH, AND POSSIBLE RUPTURE. IMAGING AND ANATOMICAL DETERMINANTS ARE INVALUABLE IN DETERMINING THE CAUSE OF THE DIFFICULTY AND WHAT, IF ANY, ADD'L ACTIONS NEED TO BE TAKEN. 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 (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR AAA REPAIR. THE PROCEDURE WAS PERFORMED AS PRESCRIBED. AFTER LEFT ILIAC LEG GRAFT WAS PLACED, CONFIRMATORY ANGIOGRAPHY REVEALED A DISTAL TYPE I ENDOLEAK. THE ADD'L ILIAC LEG GRAFT WAS PLACED TO EXTEND INTO LEFT EXTERNAL ILIAC ARTERY AND THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. FINAL ANGIOGRAPHY REVEALED ANOTHER ENDOLEAK THOUGHT TO BE A TYPE III FROM LEFT LIMB OF THE MAIN BODY. ANOTHER MFR'S STENT WAS PLACED AT THE JUNCTION PART OF THE LIMB, HOWEVER, THE ENDOLEAK WAS NOT RESOLVED. THE PHYSICIAN THOUGH THE ENDOLEAK WAS TYPE II AND TYPE IV BASED ON THE OBSERVATION OF ANGIOGRAPHY. THEN THE PHYSICIAN DECIDED TO TAKE F/U OBSERVATION. THE PT'S CONDITION AFTER THE PROCEDURE IS UNK AS IT WAS NOT PROVIDED TO THE REPORTER.

    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 F2538742

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention