BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 19347058 · Received May 17, 2024

    Report

    Report Number
    3005473391-2024-00219
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 17, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K240879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 810, 788 UPDATED/REPLACED B CODE TO INCLUDE: 4114 UPDATED/REPLACED C CODE TO INCLUDE: 3221 UPDATED/REPLACED D CODE TO INCLUDE: 67 UPDATED/REPLACED F CODE TO INCLUDE: 4641, 4607.

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN IS NOT ALLEGING THE ESOPHYX DEVICE MALFUNCTIONED THUS CONTRIBUTING TO OR CAUSING THE REPORTED PERFORATION. THE DEVICE WAS DISCARDED AT THE MEDICAL FACILITY AND IS UNAVAILABLE FOR RETURN TO ENDOGASTRIC SOLUTIONS (EGS). PER THE PHYSICIAN THE CAUSE OF THE PERFORATION IS UNKNOWN. PER THE PHYSICIAN, IF THE DEVICE WAS SCRAPPING AT THE LOCATION OF THE PERFORATION, IT WOULD BE EVIDENT DURING THE PROCEDURE AND THE DEVICE WOULD HAVE NEEDED TO BE VERY HIGH IN THE PATIENT'S ANATOMY TO CAUSE A PERFORATION IN THE OBSERVED AREA. THE PHYSICIAN BELIEVES THE NASOGASTRIC INTUBATION TUBE MAY HAVE CAUSED OR CONTRIBUTED TO THE PERFORATION. ADDITIONALLY, THE DHR WAS REVIEWED, AND THE DHR WAS FOUND TO BE IN COMPLIANCE AND NO RELATED MANUFACTURING NONCONFORMANCES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS, THE CAUSE OF THE PERFORATION CANNOT BE CONCLUSIVELY DETERMINED. IT CANNOT BE CONCLUSIVELY DETERMINED IF THE HHR PROCEDURE, USE OF MULTIPLE BOUGIES, TIF PROCEDURE, OR A COMBINATION OF THESE CONTRIBUTED TO OR CAUSED THIS ADVERSE EVENT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A CTIF PROCEDURE CONSISTING OF A HIATAL HERNIA REPAIR (HHR) PROCEDURE, CONDUCTED LAPAROSCOPICALLY, FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE). ONE 56FR BOUGIE WAS INSERTED TO DILATE THE PATIENT'S ESOPHAGUS, AND NO ISSUES WERE NOTED DURING THE SUBSEQUENT PRE-TIF EGD. A SECOND BOUGIE (60FR MOLONEY) WAS THEN USED TO DILATE THE PATIENT'S ESOPHAGUS. THE TIF PROCEDURE WAS INITIATED AND WAS STARTED IN THE ANTERIOR POSITION AS THE POSTERIOR POSITION WAS NOTED AS "COLLAPSED DOWN". A "NORMAL" AMOUNT OF BLEEDING WAS NOTED AFTER THE SECOND FASTENER DELIVERY IN THE GREATER CURVE. THE TIF PROCEDURE WAS UNEVENTFULLY COMPLETED AND THE ESOPHYX DEVICE WAS REMOVED FROM THE PATIENT. DURING THE POST-TIF PROCEDURE EGD, BLOOD WAS NOTED FROM A LOCATION ABOVE WHERE FASTENERS WERE DELIVERED CLOSER TO THE LESSER CURVE. THE TIF PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO PLACE CLIPS ENDOSCOPICALLY TO TREAT THE PERFORATION. LAPAROSCOPICALLY, THE PERFORATION WAS UNABLE TO BE LOCATED BY THE HHR PHYSICIAN AND AN INCISION WAS MADE BY THE TIF PHYSICIAN IN THE PATIENT'S STOMACH AND A STAPLE WAS PLACED AT THE SITE OF THE PERFORATION. THE PATIENT WAS DISCHARGED THE DAY AFTER THE CTIF PROCEDURE AND IS EXPECTED TO MAKE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453914 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403668 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| L