BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH

    MDR report key: 1031597 · Received April 7, 2008

    Report

    Report Number
    2017233-2007-00443
    Event Type
    Injury
    Date Received
    April 7, 2008
    Date of Event
    May 7, 2007
    Report Date
    April 4, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE WAS NOT POSSIBLE SINCE THE DEVICE LOT NUMBER WAS UNAVAILABLE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE WAS NOT POSSIBLE SINCE THE DEVICE LOT NUMBER WAS UNAVAILABLE. THIS EVENT WAS PREVIOUSLY REPORTED IN MEDWATCH #2953161-2007-00086.

    Description of Event or Problem · 1

    IN 2007, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS. AS THE 18 FRENCH GORE INTRODUCER SHEATH WAS BEING ADVANCED INTO THE CONTRALATERAL GATE OF THE TRUNK-IPSILATERAL LEG COMPONENT, THE SHEATH PUSHED THE TRUNK PROXIMALLY UNINTENTIONALLY COVERING THE LEFT RENAL ARTERY. THE PHYSICIAN PULLED THE TRUNK DISTALLY USING AN INFLATED BALLOON AND UNCOVERED THE LEFT RENAL ARTERY. THEN A SHEATH AND AN AORTIC EXTENDER WERE PROXIMALLY PLACED, HOWEVER, THE PHYSICIAN FAILED TO PULL THE SHEATH BACK BEFORE DEPLOYING THE DEVICE. AS THE SHEATH WAS BEING PULLED BACK FROM THE DEPLOYED DEVICE, THE DEVICE MOVED PROXIMALLY COVERING THE LEFT RENAL ARTERY. AN ATTEMPT WAS MADE TO PULL THE AORTIC EXTENDER BACK USING A BALLOON AS WELL AS ACCESSING THE LEFT RENAL WITH A WIRE, HOWEVER, BOTH ATTEMPTS FAILED. FINAL ANGIOGRAPHY SHOWED VERY LITTLE BLOOD FLOW TO THE LEFT RENAL ARTERY. THE RIGHT RENAL AND RIGHT KIDNEY APPEARED TO BE FUNCTIONING WELL. THE SURGEON MADE THE DECISION TO WAIT AND WATCH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH INTRODUCER SHEATH DYB W.L. GORE & ASSOCIATES, INC. WLG345 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening