BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DUALMESH BIOMATERIAL

    MDR report key: 3092353 · Received April 29, 2013

    Report

    Report Number
    2017233-2013-00265
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    May 1, 2011
    Report Date
    April 11, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    FTL
    PMA / PMN Number
    K992189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED TO GORE THAT THEY UNDERWENT A HIATAL HERNIA REPAIR. THE OPERATIVE REPORT INDICATED THAT GORE DUALMESH BIOMATERIAL WAS IMPLANTED FOR AN INCARCERATED PARAESOPHAGEAL HERNIA WITH STOMACH, SMALL BOWEL AND COLON. THE PT REPORTED HAVING DIFFICULTY SWALLOWING APPROXIMATELY TWO YEARS POST OPERATIVE AND REPORTED THAT DUE TO THIS ISSUE, THE DEVICE AS REMOVED APPROXIMATELY THREE YEARS POST IMPLANTATION. THE OPERATIVE REPORT INDICATED THAT, "THERE WAS A MODERATE-SIZED GORE-TEX PATCH, WHICH HAD BECOME DISPLACED. IT HAD ERODED INTO THE DISTAL ESOPHAGUS." THE PATCH WAS REMOVED AND THE GASTROESOPHAGEAL JUNCTION WAS REPAIRED WITH A SEROSAL PATCH. ADDITIONALLY, A CATHETER WAS BROUGHT THROUGH THE ANTERIOR ABDOMINAL WALL AND INSERTED VIA ENTEROTOMY INTO THE PROXIMAL JEJUNUM. THE OPERATIVE REPORT NOTED THAT THE PT TOLERATED THE PROCEDURE WELL. FOLLOW UP COMMUNICATION WITH THE PT REVEALED THAT THE JEJUNOSTOMY TUBE IS STILL IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184721 GORE DUALMESH BIOMATERIAL FTL/ MESH, SURGICAL, PLYMERIC FTL W.L. GORE & ASSOCIATES,INC 05466087

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention