BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3951995 · Received July 15, 2014

    Report

    Report Number
    1820334-2014-00322
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 24, 2014
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PRIOR TO (B)(6) 2014. LOT - UNKNOWN AS NOT PROVIDED BY REPORTER. EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) MALE WITH THE PREEXISTING ABDOMINAL AORTIC ANEURISM DUE TO SIGNIFICANT TYPE 1B ENDOLEAK (1820334-2014-00322) FROM EXISTING AAA GRAFT WHICH WAS IMPLANTED IN 2012 WAS HAVING EVAR PROCEDURE. THE ENDOLEAK HAD OCCURRED DUE TO PROGRESSIVE ANEURYSMAL DISEASE WITH DILATION OF THE RIGHT CIA THE PHYSICIAN ELECTED TO COME FROM THE ARM TO EMBOLIZE THE R) IIA AND HAD TO SNARE THE WIRE USING THE INDY SNARE. AS THE PHYSICIAN SNARED THE WIRE AND WITHDREW THE SNARE, THERE APPEARED TO BE RESISTANCE AND INSTEAD OF STOPPING, THE PHYSICIAN PULLED QUITE HARD AND THE LOOPED SNARE BECAME DETACHED FROM THE INDY DEVICE (1820334-2014-00314). THE PHYSICIAN TRIED UNSUCCESSFULLY TO SNARE THE INSITU NITINOL LOOPS OF THE INDY SNARE BEFORE ELECTING TO LEAVE THIS INSITU; PUSHING IT AGAINST THE WALL OF THE ARTERY WITH A ZENITH ILIAC LEG GRAFT; WHICH WAS UTILIZED TO OCCLUDE THE ENDOLEAK. THIS WAS COMPLETED SUCCESSFULLY AND THE FINAL RUN WAS GOOD DEMONSTRATING THAT THE ANEURYSMAL SAC WAS NO LONGER FILING. COOK MEDICAL SALES REP FOLLOW UP WITH THE PHYSICIAN IN THE MORNING, PATIENT WAS RECOVERING WELL AND THE PHYSICIAN WAS HAPPY WITH THE OUTCOME. THE PHYSICIAN ADVISED THE COOK REP THAT SHE DID NOT FEEL IT WAS NECESSARY TO REPORT THIS OCCURRENCE AND WAS HAPPY FOR COOK MEDICAL TO MAKE A NOTE OF THE OCCURRENCE FOR THEIR RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413094 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 90 YR Required Intervention