BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 2884991 · Received December 11, 2012

    Report

    Report Number
    3007284313-2012-00036
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 4, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A PENETRATING ATHEROSCLEROTIC ULCER OF THE THORACIC AORTA. IT WAS REPORTED THAT PREVIOUSLY THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING AN ENDURANT DEVICE. WHEN THE PHYSICIAN INSERTED THE GORE DRYSEAL SHEATH, HE FELT RESISTANCE IN THE EXTERNAL ILIAC ARTERY AND AT THE DISTAL END OF THE PREVIOUS IMPLANTED DEVICE, SO HE DECIDED TO DILATE USING A PTA BALLOON. AFTER THE DILATION THE PHYSICIAN WAS ABLE TO POSITION THE INTRODUCER SHEATH COMPLETELY INSIDE. THE CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED WITHOUT PROBLEMS. AT THE END OF THE PROCEDURE, THE COMPUTER TOMOGRAPHY ANGIOGRAPHY REVEALED A SMALL RUPTURE AND THE PHYSICIAN DECIDED TO IMPLANT A COVERED STENT FLUENCY 12 X 100 MM. THE PROBLEM WAS NOT FIXED AND THE PHYSICIAN DECIDED TO PERFORM AN OPEN SURGICAL PROCEDURE AND SUBSTITUTE THE EXTERNAL ILIAC ARTERY WITH A DACRON PROSTHESIS. 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 10767648

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R