BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 3331025 · Received August 29, 2013

    Report

    Report Number
    2017233-2013-00591
    Event Type
    Injury
    Date Received
    August 29, 2013
    Date of Event
    March 12, 2010
    Report Date
    July 30, 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

    Additional Manufacturer Narrative · 1

    RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: THE INSTRUCTIONS FOR USE FOR THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WARNS: "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."

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING TWO GORE TAG THORACIC ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT'S ACCESS VESSEL, THE RIGHT EXTERNAL ILIAC ARTERY (EIA), WAS THIN AND SIGNIFICANTLY CALCIFIED. PRIOR TO INSERTING THE GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (TS2430), THE PHYSICIAN IMPLANTED A CONTRALATERAL LEG COMPONENT (PXC) IN THE RIGHT EIA TO ALLOW THE SAFE PASSAGE OF THE SHEATH. THE PHYSICIAN TRIED TO ADVANCE THE TS2430 THROUGH THE PATIENT'S RIGHT EIA, BUT THE SHEATH WAS INTERFERED BY THE PXC AND COULD NOT GET THROUGH. DURING THIS PROCESS, THE PATIENT'S ACCESS VESSEL INTIMA FROM THE RIGHT EIA TO THE RIGHT COMMON FEMORAL ARTERY (CFA) WAS DAMAGED. AN ILIAC EXTENDER COMPONENT (PXL) WAS IMPLANTED TO REPAIR THE DAMAGED RIGHT EIA, AND INTIMECTOMY WAS ALSO PERFORMED ON THE RIGHT CFA. THE PHYSICIAN OPTED TO CREATE AN ABDOMINAL AORTIC CONDUIT AND ACCESS THE SHEATH FROM THERE. THE STENT GRAFTS WERE IMPLANTED SUCCESSFULLY WITHOUT ANY OTHER INCIDENTS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427325 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE DYB W.L. GORE & ASSOCIATES 7262459

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R