BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 2151569 · Received June 28, 2011

    Report

    Report Number
    2017233-2011-00319
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    September 15, 2009
    Report Date
    June 27, 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 MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE THE PATIENT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH A DACRON Y GRAFT. BOTH LEGS OF THE Y GRAFT HAD SEVERE TORTUOSITY. ON (B)(6), 2009, THE PATIENT UNDERWENT REPAIR OF A THORACIC AORTIC ANEURYSM. IT WAS ATTEMPTED TO ACCESS THE RIGHT FEMORAL ARTERY WITH A GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE BUT IT WAS NOT POSSIBLE. AN 8 MM STRAIGHT GRAFT WAS USED AS A CONDUIT AND CONNECTED TO THE RIGHT LEG OF THE Y GRAFT. THIS MADE IT POSSIBLE TO INSERT THE SHEATH; HOWEVER THE SHEATH PUSHED THE MIDDLE PORTION OF THE LEG OF THE Y GRAFT. THE PATIENT WAS THEN IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES. THE RIGHT LEG OF THE Y GRAFT WAS KINKED AND OCCLUDED. ONCE THE SHEATH WAS REMOVED A BYPASS SURGERY WAS PERFORMED WHERE THE DISTAL END OF THE STRAIGHT GRAFT WAS ANASTOMSED TO THE RIGHT FEMORAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE NONE DYB W.L. GORE & ASSOCIATES WLG340 06675553

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R