BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 18918841 · Received March 16, 2024

    Report

    Report Number
    3005473391-2024-00213
    Event Type
    Injury
    Date Received
    March 16, 2024
    Date of Event
    February 13, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN IS NOT ALLEGING THE ESOPHYX DEVICE MALFUNCTIONED THUS CONTRIBUTING TO OR CAUSING THE REPORTED ESOPHAGEAL TEAR, SUBSEQUENT PERFORATION, OR LEAK. THE DEVICE WAS DISCARDED AT THE MEDICAL FACILITY AND IS UNAVAILABLE FOR RETURN TO ENDOGASTRIC SOLUTIONS (EGS). THE PHYSICIAN REPORTED THE ESOPHAGEAL TEAR BEING PRESENT PRIOR TO THE INTRODUCTION OF THE ESOPHYX DEVICE AFTER USE OF THE BOUGIE WITH GUIDEWIRE. BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS, THE CAUSE OF THE REPORTED ESOPHAGEAL TEAR AND SUBSEQUENT PERFORATION, AND LEAK MAY BE DUE TO THE USE OF THE WIRE GUIDED BOUGIE OR HHR. NO ROOT CAUSE WAS IDENTIFIED; THUS, IT IS UNKNOWN IF THE HHR PROCEDURE, TIF PROCEDURE, USE OF THE BOUGIE WITH GUIDEWIRE, OR A COMBINATION OF EVENTS CONTRIBUTED TO OR CAUSED THIS ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    CORRECTIONS TO THIS MEDWATCH REPORT: D6A - IMPLANT DATE WAS ADDED B2: LIFE THREATENING UPDATED G3- DATE RECEIVED BY MANUFACTURER MERIT MEDICAL UPDATED/REPLACED G CODE TO INCLUDE 788, 810 UPDATED E CODE TO INCLUDE 2484 UPDATED/REPLACED F CODE TO INCLUDE 4607, 4617, 4624, 4641 REPLACED B CODE TO INCLUDE 4114 REPLACED C CODE TO INCLUDE 3221 REPLACED D CODE TO INCLUDE 67.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A CTIF PROCEDURE (CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE CONDUCTED EITHER LAPAROSCOPICALLY OR ROBOTICALLY, FOLLOWED CONSECUTIVELY BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). ONE BOUGIE WITH A GUIDEWIRE WAS USED PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE TO DILATE THE ESOPHAGUS. DURING THE PRE-TIF ESOPHAGOGASTRODUODENOSCOPY (EGD), PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE, AN ESOPHAGEAL TEAR WAS NOTED AT THE DISTAL ESOPHAGUS. THE PHYSICIAN PROCEEDED WITH THE TIF PROCEDURE, DESPITE THE NOTED TEAR, AND UNEVENTFULLY COMPLETED THE TIF PROCEDURE. DURING THE POST-TIF EGD, THE PREVIOUSLY NOTED ESOPHAGEAL TEAR WAS NOW NOTED AS AN ESOPHAGEAL PERFORATION. IT WAS ALSO NOTED THAT THREE ANTERIOR FASTENERS HAD BEEN TORN OUT; THE FASTENERS WERE STILL IN THE STOMACH BUT HAD PULLED OUT OF THE ESOPHAGUS. THE PHYSICIAN PLACED SUTURES AT THE SITE OF THE PERFORATION, AND A DRAIN WAS PLACED INTRA-ABDOMINALLY. THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT WAS EXTUBATED, A CHEST TUBE WAS PLACED, AND THE PATIENT WAS RE-INTUBATED. ON OF (B)(6) 2024, THE PATIENT UNDERWENT AN EGD, AND THE NOTED PERFORATION IS STILL LEAKING. AS OF (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266507 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403604 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| H| R