BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE SEAMGUARD STAPLE LINE REINFORCEMENT MAT

    MDR report key: 1060869 · Received June 13, 2008

    Report

    Report Number
    3003910212-2008-00013
    Event Type
    Death
    Date Received
    June 13, 2008
    Date of Event
    May 15, 2008
    Report Date
    June 13, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE BY THE PHYSICIAN, GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (IMPLANT DATE NOT PROVIDED) WAS USED FOR A PULMONARY SEGMENTECTOMY IN A LUNG CANCER PATIENT. THE PATIENT DEVELOPED HEMOPTYSIS (DATE NOT PROVIDED) AND DIED AT HOME IN 2008. THE PHYSICIAN REPORTED THE AUTOPSY REVEALED FISTULA FORMATION FROM THE AORTA TO THE SURGICAL SITE CAUSING BLOOD COLLECTION INTO THE THORACIC CAVITY. NO DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MAT NONE FTL W.L. GORE & ASSOCIATES,INC WLG201

    Patients

    Seq Age Sex Outcome Treatment
    1 Death