BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT

    MDR report key: 12785749 · Received November 10, 2021

    Report

    Report Number
    3003910212-2021-01315
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    June 19, 2012
    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 B7 AND H6-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
    1684001 GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL FTM W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other