BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT

    MDR report key: 12779262 · Received November 9, 2021

    Report

    Report Number
    3003910212-2021-01311
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    June 22, 2020
    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

    H6 - CODE 4111: MULTIPLE ATTEMPTS HAVE BEEN MADE TO ACQUIRE ADDITIONAL INFORMATION TO CLASSIFY ANY POSSIBLE SPECIFIC DEVICE PROBLEM, DEVICE IDENTIFICATION, AND EVENT DATES. THE AUTHOR OF THE LITERATURE ARTICLE DID NOT REPLY. UPDATE COMPONENT CODE.

    Additional Manufacturer Narrative · 0

    NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. THE MEAN AGE AMONG THE PATIENTS WAS REPORTED TO 44.6 YEARS WHERE THE MAJORITY OF THE PATENTS ARE FEMALE. THE AVERAGE WEIGHT WAS REPORTED 112.5 KG. THE DATE OF INCIDENT IS UNKNOWN. THEREFORE, THE ONLINE PUBLICATION DATE OF THE LITERATURE ARTICLE IS USED AS DATE OF INCIDENT. 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: ENDOSCOPY 2021; 53: 235¿243. 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: GONTRAND LOPEZ-NAVA, RAVISHANKAR ASOKKUMAR, INMACULADA BAUTISTA-CASTAÑO, JANESE LASTER, ANURADHA NEGI, STEPHANIE FOOK-CHONG, JAVIER NEBREDA DURAN, EDUARD ESPINETT COLL, JORDI PUJOL GEBELLI, AMADOR GARCIA RUIZ DE GORDEJUELA. TITLE: ENDOSCOPIC SLEEVE GASTROPLASTY, LAPAROSCOPIC SLEEVE GASTRECTOMY, AND LAPAROSCOPIC GREATER CURVE PLICATION: DO THEY DIFFER AT 2 YEARS? PUBLISHED ONLINE JUN 22, 2020 IN ENDOSCOPY (ENDOSCOPY 2021; 53: 235¿243). FROM JANUARY 2014 TO APRIL 2016, DATA OF 61 PATIENTS WHICH UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) WERE COLLECTED FROM BELVITGE UNIVERSITY HOSPITAL, BARCELONA, SPAIN, WITH THE AIM OF COMPARING THE EFFECTIVENESS AND SAFETY OF ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) WITH LSG AND LAPAROSCOPIC GREATER CURVE PLICATION (LGCP). ON ALL PATIENTS OPERATED FOR LSG, STAPLES REINFORCED WITH GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WERE USED. OUT OF THESE 61 PATIENTS, 2 PATIENTS DEVELOPING HEMOPERITONEUM AND REQUIRED SURGERY. 1 PATIENT DEVELOPED MILD HEMOPERITONEUM AND WAS TREATED CONSERVATIVELY WITHOUT ANY FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676742 GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL FTM W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other