BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3760971 · Received April 10, 2014

    Report

    Report Number
    1820334-2014-00158
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT, WITH AN ANGULATED NECK (SOME RIGHT TO LEFT ANGULATION IN THE NECK AS WELL AS SOME SLIGHT ANTERIOR ANGULATION) AND HEAVY CALCIUM IN THE LEFT ILIAC AND MODERATE CALCIUM IN THE RIGHT COMMON ILIAC, UNDERWENT EVAR ON (B)(6) 2014. THE DEVICE (NOT MODIFIED IN ANY WAY PRIOR TO USE) DEPLOYED HIGHER THAN INTENDED IN THE PATIENTS ANATOMY AND THUS COVERED THE PATIENTS LOWEST LEFT RENAL ARTERY. THE PHYSICIAN WAS NOT AWARE UNTIL THE FINAL RUN AT THE END OF THE PROCEDURE. MULTIPLE EFFORTS WERE MADE FROM BELOW TO TRY AND SELECT THE ARTERY WITH A BENTSON WIRE AND MULTIPLE CATHETERS WERE UNSUCCESSFUL. THEN THE LEFT ARM WAS PREPPED OUT, AND MULTIPLE ATTEMPTS WERE MADE FROM ABOVE TO TRY AND GET BEHIND THE GRAFT AND INTO THE RENAL ARTERY WERE UNSUCCESSFUL AS WELL. THE PHYSICIAN ENDED UP LEAVING THE PROCEDURE WITH THE LEFT RENAL ARTERY COVERED. THE PHYSICIAN SAID AFTER THE CASE THAT THE PATIENT WAS STILL MAKING URINE, AND SAID HE HAD SPOKEN WITH THE FAMILY AND THEY WERE UNDERSTANDING. AS OF (B)(6) 2014 AT 0900, THE PHYSICIAN STATED THAT THE PATIENT HAD BEEN REMITTED WITH MULTIPLE ISSUES BUT DID NOT GO INTO ANY DETAIL. THE REP WILL FOLLOW UP WITH HIM. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216214 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC. NA 4259698

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability