BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

    MDR report key: 4181825 · Received October 17, 2014

    Report

    Report Number
    3003910212-2014-00024
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 12, 2014
    Report Date
    October 1, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTM
    PMA / PMN Number
    K043056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: BARRETO TW, KEMMETER P, PALETTA M, ALAN D. A COMPARISON OF A SINGLE CENTER¿S EXPERIENCE WITH THREE STAPLE LINE REINFORCEMENT TECHNIQUES IN 1,502 LAPAROSCOPIC SLEEVE GASTRECTOMY PATIENTS. OBES SURG. 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED IN LITERATURE THAT A RETROSPECTIVE REVIEW OF 1,526 PATIENT CHARTS WAS PERFORMED TO COMPARE THE OUTCOMES OF LAPAROSCOPIC SLEEVE GASTRECTOMY BASED ON THREE TYPES OF STAPLE LINE REINFORCEMENT (IMBRICATION, BOVINE PERICARDIAL STRIPS, AND ABSORBABLE POLYMER MEMBRANE). OF THE 860 PATIENTS THAT UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY USING APM (ENDOSCOPIC GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT), 3 PATIENTS EXPERIENCED A LEAK. IT WAS REPORTED THAT THE LEAKS WERE DIAGNOSED RADIOLOGICALLY AND INTRAOPERATIVELY AND ASSUMED FROM FINDINGS OF AN ABSCESS OR OTHER CLINICAL FINDINGS. IT IS UNCLEAR HOW LEAKS WERE DIAGNOSED AMONG THE APM GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662263 GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL MESH, SURGICAL FTM W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention