BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 2042098 · Received March 29, 2011

    Report

    Report Number
    2017233-2011-00156
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 28, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS TREATED FOR AN INFRARENAL AORTIC ANEURYSM WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. THE THREE GORE EXCLUDER AAA ENDOPROSTHESIS WERE LANDED AS INTENDED AND THE ANEURYSM APPEARED TO BE EXCLUDED. AS THE PHYSICIAN WAS COMPLETING THE PROCEDURE, THE PT'S BLOOD PRESSURE DROPPED TO ZERO. THE PHYSICIAN FOUND THAT THE LEFT EXTERNAL ILIAC HAD RUPTURED WHEN THE 20 FR GORE DRYSEAL SHEATH WAS BEING WITHDRAWN. THE MEASUREMENT OF THE LEFT EXTERNAL ILIAC WAS 8.8 MM. THE PT CODED. THE PT LOST 6 LITERS OF BLOOD LOSS. THE ANEURYSM WAS EXCLUDED AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DRYSEAL SHEATH DYB / INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES WLG001 8379048

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R