BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 3030623 · Received March 25, 2013

    Report

    Report Number
    3007284313-2013-00017
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    W. L. GORE ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE DRYSEAL SHEATH SIZING GUIDE, THE OUTSIDE DIAMETER OF THE 24FR GORE DRYSEAL SHEATH IS 9.1MM. IT WAS REPORTED THAT THE DIAMETER OF THE EXTERNAL ILIAC ARTERY WAS LESS THAN 9MM.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM, PRESENT IN THE AORTIC ARCH, USING GORE TAG THORACIC ENDOPROSTHESIS. PRIOR TO THE TAG IMPLANTATION BUT DURING THE SAME PROCEDURE, THE PHYSICIAN PERFORMED A TOTAL DEBRANCHING OF THE ASCENDING AORTA. AFTER THE DEBRANCHING PROCEDURE, THE PHYSICIAN ADVANCED THE 24FR GORE DRYSEAL SHEATH FROM THE RIGHT FEMORAL ARTERY. TWO TAG DEVICES WERE IMPLANTED. RETRACTION OF THE SHEATH RESULTED IN VESSEL TRAUMA TO THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN REPAIRED THE TRAUMA USING AN ILIAC EXTENDER COMPONENT. THE PATIENT TOLERATED THE PROCEDURE. ACCORDING TO THE PHYSICIAN, A DIAMETER OF THE EXTERNAL ILIAC ARTERY WAS LESS THAN 9MM. THE PHYSICIAN ALSO STATED THAT THERE WAS RESISTANCE DURING INSERTION OF THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122081 GORE DRYSEAL SHEATH DYB / INTRODUCER, CATHETER DYB W. L. GORE ASSOCIATES 10433616

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention