BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT

    MDR report key: 10244207 · Received July 8, 2020

    Report

    Report Number
    3003910212-2020-00114
    Event Type
    Injury
    Date Received
    July 8, 2020
    Date of Event
    April 16, 2018
    Report Date
    June 12, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTM
    PMA / PMN Number
    K043056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REQUESTED BUT NO INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION SUCH AS DATE OF EVENTS, LOT/SERIAL NUMBERS WERE REQUESTED, BUT NO INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WHICH MENTIONS GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WAS REVIEWED: RETROSPECTIVE COMPARISON OF SINGLE-PORT SLEEVE GASTRECTOMY VERSUS THREE-PORT LAPAROSCOPIC SLEEVE GASTRECTOMY: A PROPENSITY SCORE ADJUSTMENT ANALYSIS. PURPOSE: EVALUATE THE EFFICACY OF SINGLE-PORT SLEEVE GASTRECTOMY (SPSG) AND THEN COMPARE IT TO A LESS-INVASIVE SLEEVE APPROACH (THREE-PORT) (3PSG) ACCORDING TO A PROPENSITY SCORE (PS) MATCHING ANALYSIS. MATERIALS AND METHODS: WE ANALYZED ALL PATIENTS WHO UNDERWENT SG THROUGH A THREE-PORT OR A SINGLE-PORT LAPAROSCOPIC APPROACH. RESULTS: AFTER 2 YEARS, THE FOLLOW-UP WAS COMPLETED IN 84% PATIENTS TREATED WITH 3PSG AND 95% PATIENTS OF THE SPSG GROUP. EXCESS WEIGHT LOSS (EWL) WAS COMPARABLE FOR THE FIRST YEAR OF FOLLOW-UP WITHIN THE TWO GROUPS EXCEPT FOR THE CONTROLS AT 3 MONTHS IN WHICH THE SPSG GROUP SHOWED A HIGHER EWL. CONCLUSION: WE DEMONSTRATED THE EFFICACY OF SPSG IN BARIATRIC SURGERY EVEN COMPARED TO ANOTHER, LESS INVASIVE, LAPAROSCOPIC SG APPROACH (THREE-PORT). THE ARTICLE REPORTS, "LAPAROSCOPY REVISION FOR BLEEDING ON THE CUTTING LINE WAS REQUIRED IN TWO PATIENTS OF THE 3PSG GROUP AND ONE PATIENT OF THE SPSG GROUP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708272 ENDOSCOPIC GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL FTM W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention