BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3122146 · Received May 17, 2013

    Report

    Report Number
    1820334-2013-00237
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH A SOMEWHAT CALCIFIED BUT NOT REALLY TORTUOUS ANATOMY, UNDERWENT INITIAL EVAR ON (B)(6) 2010. THE PHYSICIAN PLACED ON FLEX MAIN BODY AND TWO ILIAC LIMBS. OVER TIME, THE ANEURYSM CONTINUED TO SHRINK UP TO 2 CM. HOWEVER, ADDITIONAL FOLLOW UPS (ANGIO AND CT) INDICATED THAT THE ANEURYSM STARTED TO GROW AGAIN AND AFTER A FEW FOLLOW UPS HAD GROWN BACK ALMOST TO THE SIZE PRE-IMPLANT. THE PHYSICIAN STATED THAT THE ANEURYSM CONTINUED TO GROW AND WAS INFLAMED DUE TO THE PATIENT'S CONTINUED SMOKING. THERE WERE NO SIGNS OF ENDOLEAK AT ALL. THE PHYSICIAN THEN DECIDED TO EXTRACT THE MAIN BODY SO ON (B)(6) 2013, HE EXPLANTED PART OF THE MAIN BODY. HE LEFT IN THE ILIAC LIMBS AND THE SUPRARENAL STENT AND SEWED THE MATERIAL TO THE GRAFTS THAT WERE LEFT IN PLACE. THE OUTCOME WAS GOOD AND THE PATIENT IS DOING WELL AND HAS NOW QUIT SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219189 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA 2362105

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention