BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 1821207 · Received August 27, 2010

    Report

    Report Number
    2017233-2010-00384
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 26, 2010
    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 MANUFACTURING RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4). THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), STATES: SUCCESSFUL PATIENT SELECTION REQUIRES SPECIFIC IMAGING AND ACCURATE MEASUREMENTS; ADEQUATE ILIAC OR FEMORAL ACCESS IS REQUIRED TO INTRODUCE THE DEVICE INTO THE VASCULATURE. CAREFUL EVALUATION OF VESSEL SIZE, ANATOMY AND DISEASE STATE IS REQUIRED TO ASSURE SUCCESSFUL SHEATH INTRODUCTION AND SUBSEQUENT WITHDRAWAL. A SURGICALLY CREATED VASCULAR CONDUIT MAY BE NEEDED TO ACHIEVE ACCESS IN SELECT PATIENTS. THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE INSTRUCTIONS FOR USE (IFU), STATES: 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 PATIENT INCLUDING DEATH MAY RESULT. THE 22 FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE HAS AN OUTER DIAMETER OF 8.3 MM.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT A PROCEDURE FOR TREATMENT OF AN AORTIC ARCH DISSECTION OF THE DESCENDING THORACIC AORTA. A GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WAS USED TO ADVANCE A GORE TAG THORACIC ENDOPROSTHESIS FOR IMPLANT. THE SHEATH WAS INSERTED INTO THE RIGHT FEMORAL ARTERY. ALTHOUGH THERE WAS STRONG RESISTANCE, THE INTRODUCER SHEATH WAS ADVANCED INTO POSITION AND IMPLANTED. BALLOONING OF THE AREA WAS PERFORMED. UPON REMOVAL OF THE INTRODUCER SHEATH, THE PATIENT'S BLOOD PRESSURE DROPPED TO THE 40'S (MMHG). THE PHYSICIAN DIAGNOSED A RUPTURE OF THE ACCESS VESSEL. TWO GORE ILIAC EXTENDER COMPONENTS WERE IMPLANTED AT THE JUNCTION OF THE RIGHT COMMON, AND EXTERNAL ILIAC ARTERIES. THE RUPTURED WAS REPAIRED, BUT LEAKING WAS STILL PRESENT. A FEMORAL CROSSOVER BYPASS WAS PERFORMED USING AN UNKNOWN GRAFT. THE PATIENT TOLERATED THE PROCEDURE, AND IS DOING WELL. THE PHYSICIAN STATED HE WAS PREPARED FOR DAMAGE OR RUPTURE OF THE ACCESS BLOOD VESSEL, AND THAT THE DEVICE DID NOT CAUSE THE INCIDENT.

    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 WLG340 7808812

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O