BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

    MDR report key: 2062707 · Received April 12, 2011

    Report

    Report Number
    3003910212-2011-00007
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 9, 2011
    Report Date
    April 11, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTM
    PMA / PMN Number
    K043056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVAL. LOT NUMBER INFO WAS NOT PROVIDED, THEREFORE, A REVIEW OF QUALITY RECORDS COULD NOT BE PERFORMED. THE DEVICE REMAINS IMPLANTED, THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFO, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED, BUT THERE IS NO INDICATION THAT A DEVICE DEFECT OR MALFUNCTION WAS INVOLVED. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE FOR USE IN TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT A PT DEVELOPED A LEAK AT THE STAPLE LINE AFTER UNDERGOING A LAPAROSCOPIC SLEEVE GASTRECTOMY WHERE GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL WAS USED. THE PT UNDERWENT ANOTHER PROCEDURE TO REPAIR THE LEAK. THE REOPERATION WAS SUCCESSFUL AND THE PT IS REPORTED TO BE FINE. THE PHYSICIAN REPORTED THAT THE LEAKAGE MAY HAVE BEEN CAUSED BY THE PT WHEN SHE DRANK A LARGE AMOUNT OF WATER POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL FTM/MESH, SURGICAL FTM W.L. GORE & ASSOCIATES WLG520

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention