BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 2002379 · Received February 16, 2011

    Report

    Report Number
    2017233-2011-00071
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 16, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    PMA / PMN Number
    K032073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ACCORDING TO THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE INSTRUCTIONS FOR USE, ENSURE THE VESSEL IS OF ADEQUATE SIZE AND APPROPRIATE TORTUOSITY FOR THE INSERTION OF THE INTRODUCER SHEATH. IF THE VESSEL IS TOO SMALL, MAJOR BLEEDING, VESSEL RUPTURE/PERFORATION, AND SERIOUS INJURY TO THE PATIENT INCLUDING DEATH MAY RESULT. DO NOT ATTEMPT TO ADVANCE OR WITHDRAW GUIDEWIRE, CATHETER, OR OTHER DEVICE THROUGH THE INTRODUCER SHEATH AND/OR DILATOR IF RESISTANCE IS FELT. USE FLUOROSCOPY TO DETERMINE THE CAUSE. CONTINUED ADVANCEMENT OR RETRACTION AGAINST RESISTANCE MAY RESULT IN SERIOUS INJURY TO THE PATIENT, DAMAGE TO OR BREAKAGE OF THE GUIDEWIRE, CATHETER, OR OTHER DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT REPAIR OF A THORACIC AORTIC ANEURYSM. A 24 FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WAS ADVANCED WITH STRONG RESISTANCE. TWO GORE TAG THORACIC ENDOPROSTHESES WERE IMPLANTED. UPON REMOVAL OF THE 24 FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE, THERE WAS AGAIN STRONG RESISTANCE. THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY AND RIGHT INTERNAL ILIAC ARTERY WERE RUPTURED AND REPAIRED USING A DACRON GRAFT. THE PATIENT TOLERATED THE PROCEDURE. THE DIAMETER OF THE EXTERNAL ILIAC ARTERY WAS 7.9-8.2 MM. THE 24 FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE IS FOR A VESSEL DIAMETER OF 9.1 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE DYB / INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES, INC. WLG 8134787

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R