BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 19084349 · Received April 10, 2024

    Report

    Report Number
    3005473391-2024-00217
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    February 26, 2024
    Report Date
    August 24, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN IS NOT ALLEGING A PRODUCT MALFUNCTION CONTRIBUTED TO OR CAUSED THE ADVERSE EVENT AND THE DEVICE WAS NOT RETURNED TO ENDOGASTRIC SOLUTIONS (EGS) FOR EVALUATION. THE DEVICE WAS DISCARDED AT THE MEDICAL FACILITY BY HOSPITAL STAFF AND IS UNAVAILABLE FOR RETURN TO EGS. PER THE PHYSICIAN, THE PULMONARY EMBOLISM POSSIBLY OCCURRED DUE TO DISTANT HISTORY OF PULMONARY EMBOLISM. BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS, THE CAUSE OF THE REPORTED PULMONARY EMBOLISM CANNOT BE CONCLUSIVELY DETERMINED. IT CANNOT BE CONCLUSIVELY DETERMINED IF THE PATIENTS PRIOR HISTORY OF PULMONARY EMBOLISM DIAGNOSIS, HHR PROCEDURE, TIF PROCEDURE, OR A COMBINATION OF BOTH THESE CONTRIBUTED TO OR CAUSED THIS ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW OF EGS COMPLAINTS [(B)(4)] BY MERIT MEDICAL'S SYSTEMS INC, [(B)(4)] PMS TEAM FOR ANY IDENTIFIED COMPLAINT DISCREPANCIES REQUIRING CORRECTIONS/ADDITIONAL INFORMATION PER 21 CFR 803. MERIT MEDICAL SYSTEMS INC. (B)(6). CORRECTIONS TO THIS MEDWATCH REPORT: D6A - IMPLANT DATE WAS ADDED UPDATED G3- DATE RECEIVED BY MANUFACTURER MERIT MEDICAL UPDATED/REPLACED G CODE TO INCLUDE: 788 UPDATED/REPLACED B CODE TO INCLUDE: 4114 UPDATED/REPLACED C CODE TO INCLUDE: 3221 UPDATED/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 BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). THE TIF PROCEDURE WAS UNEVENTFULLY COMPLETED, AND THE PATIENT WAS DISCHARGED. ON THE NEXT DAY FOLLOWING THE PROCEDURES, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF SHORTNESS OF BREATH AND WAS ADMITTED. THE PATIENT UNDERWENT BLOODWORK AND A CT SCAN ON AN UNKNOWN DATE AND WAS DIAGNOSED WITH A PULMONARY EMBOLISM. ANTICOAGULANT MEDICATION WAS ADMINISTERED. THE PATIENT WAS DISCHARGED ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867865 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403587 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Life Threatening| H| R