BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 2132220 · Received June 14, 2011

    Report

    Report Number
    2017233-2011-00281
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 13, 2009
    Report Date
    June 14, 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 VESSEL DIAMETER NEEDED FOR THE SHEATH IS 8.3 MM. 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 VESSEL IS TOO SMALL, MAJOR BLEEDING, VESSEL RUPTURE/PERFORATION, AND SERIOUS INJURY TO THE PT INCLUDING DEATH MAY RESULT.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT UNDERWENT REPAIR OF A THORACIC AORTIC ANEURYSM. A 22 FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WAS ADVANCED RUPTURING THE EXTERNAL ILIAC ARTERY. THE RIGHT EXTERNAL ILIAC ARTERY WAS ANASTOMOSED WITH A 10 MM DACRON GRAFT. AFTER USING THE GRAFT AS A CONDUIT TO IMPLANT A GORE TAG THORACIC ENDOPROSTHESIS, AN ILIO-FEMORAL BYPASS WAS PERFORMED. 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 WLG340 06496629

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R