BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

    MDR report key: 1730503 · Received June 16, 2010

    Report

    Report Number
    2017233-2010-00282
    Event Type
    Injury
    Date Received
    June 16, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 16, 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 PAPERWORK IS BEING CONDUCTED. PLEASE NOTE: DEVICE USED IN REPAIR OF THE DISRUPTION: PXC121200/6971440. ACCORDING TO THE INSTRUCTIONS FOR USE, THE GORE EXCLUDER AAA ENDOPROSTHESIS IS INTENDED TO EXCLUDE AN ANEURYSM FROM THE BLOOD CIRCULATION IN PTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ANEURYSM OF THE ASCENDING THORACIC AORTA USING GORE TAG THORACIC ENDOPROSTHESES. REMOVAL OF THE 22FR GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE RESULTED IN TRAUMATIC DISRUPTION OF THE LEFT EXTERNAL ILIAC ARTERY. A CONTRALATERAL LEG COMPONENT WAS USED TO REPAIR THE TRAUMATIC DISRUPTION. BLOOD LOSS WAS LESS THAN 1 LITER. ON (B) (6) 2010, THE PT UNDERWENT OPEN SURGERY DUE TO BLEEDING FROM THE ANASTOMOSIS BETWEEN THE CONTRALATERAL LEG COMPONENT AND THE EXTERNAL ILIAC ARTERY. THE CONTRALATERAL LEG COMPONENT WAS EXPLANTED AND REPLACED WITH VASCULAR GRAFT. 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 7652362

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R