BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTRODUCER SHEATH

    MDR report key: 880535 · Received July 13, 2007

    Report

    Report Number
    2017233-2007-00204
    Event Type
    Injury
    Date Received
    July 13, 2007
    Date of Event
    May 25, 2007
    Report Date
    July 12, 2007
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY. PLEASE NOTE: IN 2007, A GORE TAG THORACIC ENDOPROSTHESIS (LOT#4840135) WAS IMPLANTED.

    Description of Event or Problem · 1

    IN 2007, A GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED TO REPAIR A DESCENDING THORACIC AORTIC ANEURYSM. THE NEXT DAY, THE PT PRESENTED WITH A RIGHT GROIN HEMATOMA; THE HEMATOMA WAS SURGICALLY REPAIRED. IT WAS REPORTED THAT THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH INTRODUCER SHEATH DYB W.L. GORE & ASSOCIATES,INC WLG340 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention