BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE BIO-A TISSUE REINFORCEMENT

    MDR report key: 1901366 · Received November 12, 2010

    Report

    Report Number
    3003910212-2010-00016
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    September 19, 2010
    Report Date
    November 12, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K033671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE WAS NOT RETURNED FOR EVALUATION. RESULTS - REVIEW OF QUALITY RECORDS. THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. BASED UPON THE AVAILABLE INFORMATION, THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED, BUT THERE IS NO INDICATION THAT A DEVICE DEFECT OR MALFUNCTION WAS INVOLVED. THE GORE BIO-A TISSUE REINFORCEMENT MATERIAL IS PROVIDED STERILE FOR SINGLE USE ONLY. THE INSTRUCTIONS-FOR-USE IDENTIFIES THE POSSIBLE ADVERSE REACTIONS WITH THE FOLLOWING STATEMENT, "POSSIBLE ADVERSE REACTIONS MAY INCLUDE, BUT ARE NOT LIMITED TO, INFECTION, INFLAMMATION, ADHESIONS AND SEROMA FORMATION" WHICH ARE CONSISTENT WITH THE ANTICIPATED, POTENTIAL COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE ITSELF. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. ALL AVAILABLE INFORMATION 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 PATIENT UNDERWENT EMERGENCY SURGERY SIX DAYS AFTER UNDERGOING A FUNDOPLICATION PROCEDURE TO REPAIR A HIATAL HERNIA WHERE GORE BIO-A TISSUE REINFORCEMENT MATERIAL WAS USED. THE PATIENT WAS REPORTED TO HAVE DEVELOPED A SUBPHRENICAL ABSCESS AT THE HIATUS REQUIRING REMOVAL OF THE DEVICE. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE BIO-A TISSUE REINFORCEMENT FTL / MESH, SURGICAL, POLYMERIC FTL W.L. GORE & ASSOCIATES WLG540 7072345

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention