BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 3092323 · Received April 25, 2013

    Report

    Report Number
    2017233-2013-00261
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    May 9, 2009
    Report Date
    March 27, 2013
    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

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DISSECTED THORACIC AORTA USING GORE TAG THORACIC ENDOPROSTHESIS. THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, THROUGH WHICH THE TAG DEVICE WAS SUCCESSFULLY IMPLANTED. THE DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY WAS LESS THAN 8.3MM. THE DIAMETER OF THE RIGHT FEMORAL ARTERY WAS NOT AVAILABLE. REMOVAL OF THE SHEATH RESULTED IN A DISSECTION AT THE RIGHT FEMORAL ARTERY. A SMART STENT WAS IMPLANTED TO REPAIR THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179033 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE DYB/INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES 06515370

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention