BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT

    MDR report key: 12785742 · Received November 10, 2021

    Report

    Report Number
    3003910212-2021-01314
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    June 15, 2010
    Report Date
    November 24, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    FTM
    PMA / PMN Number
    K030782
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT IDENTIFIER HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. ENGINEERING EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. LITERATURE CITATION: SURG OBES RELAT DIS. MAR-APR 2015;11(2):296-301.

    Additional Manufacturer Narrative · 0

    H6 - CODE 4111: THE AUTHOR OF THE ARTICLE WAS CONTACTED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE ADVERSE EVENTS. THE AUTHOR PROVIDED PATIENT DETAILS AS WELL AS PRIOR HEALTH CONDITIONS. UPDATE COMPONENT CODE. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT, POSSIBLE ADVERSE REACTIONS MAY INCLUDE, BUT ARE NOT LIMITED TO: ADHESIONS, HEMATOMA, INFECTION, AND INFLAMMATION.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: CARLOS RODRÍGUEZ-OTERO LUPPI, CARMEN BALAGUÉ, EDUARD M. TARGARONA, SORIN MOCANU, JESÚS BOLLO, CARMEN MARTÍNEZ, AND MANEL TRIAS. TITLE: LAPAROSCOPIC SLEEVE GASTRECTOMY IN PATIENTS OVER 60 YEARS: IMPACT OF AGE ON WEIGHT LOSS AND CO-MORBIDITY IMPROVEMENT. PUBLISHED ONLINE JUN 2, 2014 IN SURGERY FOR OBESITY AND RELATED DISEASES (SURG OBES RELAT DIS. MAR-APR 2015;11(2):296-301). 130 PATIENTS UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG). ON ALL PATIENTS, STAPLES REINFORCED WITH GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WERE USED. 1 PATIENT REQUIRED SURGICAL REINTERVENTION DUE TO STAPLE LINE LEAK/FISTULA, WHICH WAS APPROACHED LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689760 GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL FTM W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other