BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 2170679 · Received July 12, 2011

    Report

    Report Number
    2017233-2011-00341
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 12, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    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 MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE 24 FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE USED IS FOR A VESSEL DIAMETER OF 9.1 MM. PER THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE INSTRUCTIONS FOR USE (IFU), ENSURE THE VESSEL IS OF ADEQUATE SIZE AND APPROPRIATE TORTUOSITY FOR THE INSERTION OF THE INTRODUCER SHEATH. IF VESSEL IS TOO SMALL, MAJOR BLEEDING, VESSEL RUPTURE/PERFORATION, AND SERIOUS INJURY TO THE PT 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 PT, DAMAGE TO OR BREAKAGE OF THE GUIDEWIRE, CATHETER, OR OTHER DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT REPAIR OF A THORACIC AORTIC ANEURYSM AND AN ABDOMINAL AORTIC ANEURYSM. THE THORACIC AORTIC ANEURYSM WAS REPAIRED FIRST. STRONG RESISTANCE WAS FELT WHEN INSERTING THE 24 FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE. A GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED AND UPON REMOVAL OF THE SHEATH THE ACCESS VESSEL WAS RUPTURED. TWO GORE EXCLUDER AAA ENDOPROSTHESES ILIAC EXTENDER COMPONENTS WERE IMPLANTED REPAIRING THE RUPTURED VESSEL. THEN AN AUI AND A FEMORAL-FEMORAL BYPASS SURGERY WERE PERFORMED USING THREE AORTIC EXTENDER COMPONENTS. THE PT TOLERATED THE PROCEDURE.

    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 WLG440 8875284

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R