BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 10928824 · Received December 1, 2020

    Report

    Report Number
    3005473391-2020-00140
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 13, 2020
    Report Date
    December 1, 2020
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ENDOGASTRIC SOLUTIONS (EGS) CLINICAL SPECIALIST AND PROGRAM DEVELOPMENT MANAGER WERE PRESENT DURING THE TIF PORTION OF THE PROCEDURE AND DID NOT NOTE ANY UNUSUAL PHYSICIAN TECHNIQUE NOR ANY PATIENT ISSUES DURING THE TIF PROCEDURE. AS PER EGS POLICY, EGS PERSONNEL WERE NOT PRESENT DURING THE HIATAL HERNIA REPAIR PORTION OF THE CONCOMITANT PROCEDURE. THE PHYSICIAN IS NOT ALLEGING A PRODUCT MALFUNCTION OCCURRED TO CAUSE OR CONTRIBUTE TO THE PATIENT ADVERSE EVENT. THE DEVICE WAS NOT RETURNED TO EGS FOR EVALUATION. THE PHYSICIAN IS UNABLE TO CONFIRM WHETHER THE TIF PROCEDURE AND/OR THE HIATAL HERNIA REPAIR CAUSED OR CONTRIBUTED TO THE PATIENT'S ADVERSE EVENT.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A HIATAL HERNIA REPAIR AND TIF CONCOMITANT PROCEDURE. PRIOR TO INSERTION OF THE ESOPHYX DEVICE, A BOUGIE WITH A GUIDEWIRE WAS USED TO DILATE THE ESOPHAGUS AFTER THE HERNIA REPAIR. DURING ESOPHYX DEVICE INSERTION, A SMALL FLAP OF TISSUE WAS NOTED AT THE GEJ BUT WAS REPORTED BY THE PHYSICIAN AS INSIGNIFICANT. THROUGHOUT THE ENTIRE TIF PROCEDURE, ACHIEVING FULL STOMACH INSUFFLATION WAS DIFFICULT. THE TIF PROCEDURE WAS THEN COMPLETED WITH NO ESOPHYX DEVICE ISSUES NOTED. AT SOME POINT POST-PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN. AN XRAY SHOWED OPACIFICATION OF THE LEFT LUNG, A LARGE AIR BUBBLE IN THE PATIENT'S CHEST, AND A COLLAPSED LEFT LUNG. THE RADIOLOGIST ALSO NOTED THE PATIENT HAD A HIATAL HERNIA. IT IS UNKNOWN IF THE HIATAL HERNIA WAS IN THE SAME LOCATION AS PREVIOUS HIATAL HERNIA (RECURRENCE) OR A NEW LOCATION. AN UPPER ENDOSCOPY WAS PERFORMED, AND THE RECURRENCE OF A HIATAL HERNIA WAS VISUALLY CONFIRMED. A CT SCAN WAS ALSO PERFORMED AND A PERFORATION AT THE GEJ WAS NOTED. THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL FACILITY FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391922 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization