BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

    MDR report key: 3651520 · Received February 27, 2014

    Report

    Report Number
    3003910212-2014-00003
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTM
    PMA / PMN Number
    K043056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ALL INFORMATION HAS BEEN MADE AVAILABLE FOR TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE COMPLAINANT ADVISED THE GORE REPRESENTATIVE OF THE FOLLOWING: THE PATIENT SUFFERED FROM SLEEP APN[O]EA AND PRESENTED FOR A LAP SLEEVE GASTRECTOMY. SIX PIECES OF ENDOSCOPIC GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT WERE IMPLANTED. THE PATIENT HAD IMMEDIATE POST OP HYPERTENSION AND WAS GIVEN A NUMBER OF MEDICATIONS TO REDUCE BLOOD PRESSURE. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS VERY DIFFICULT AND AT 6 HOURS POST OP THE PATIENT WAS THOUGHT TO HAVE SOME DEGREE OF BLEEDING. THE PATIENT BECAME UNSTABLE AND THEN STABILIZED, BUT AT 15 HOURS POST OP, THE PATIENT REQUIRED REVISIONAL SURGERY TO CONTROL BLEEDING. DURING THE REVISION PROCEDURE, THE SURGEON OBSERVED BLEEDING AT THE 5TH FIRING OUT OF 6 FIRINGS NEAR THE CARDIO ESOPHAGEAL JUNCTION OF THE STOMACH. THE PATIENT LOST 3.5 ¿ 4 LITERS OF BLOOD AND REQUIRED A BLOOD TRANSFUSION. ACCORDING TO THE PHYSICIAN, THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121781 GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL MESH, SURGICAL FTM W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention