BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESOPHYX Z+

    MDR report key: 18553327 · Received January 22, 2024

    Report

    Report Number
    3005473391-2024-00208
    Event Type
    Death
    Date Received
    January 22, 2024
    Date of Event
    November 15, 2023
    Report Date
    April 29, 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 ESOPHYX DEVICE WAS DISCARDED AT THE MEDICAL FACILITY BY THE HOSPITAL STAFF AND IS UNAVAILABLE FOR RETURN TO EGS FOR EVALUATION. THE TIF PHYSICIAN STATED THAT THE CAUSE OF THE POST PROCEDURE EVENT MAY BE DUE TO PERFORATION OR FASTENER EROSION. THE PHYSICIAN ALSO INDICATED THAT THE PATIENT'S UNDERLYING UNKNOWN/UNDIAGNOSED COMORBIDITIES (INCLUDING CORONARY ARTERY DISEASE) MAY HAVE CONTRIBUTED TO OR CAUSED THE PATIENT'S OUTCOME. THUS, IT IS UNKNOWN IF THE TIF PROCEDURE CONTRIBUTED TO AND/OR CAUSED THE PATIENT'S OUTCOME. BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS AND THE MEDICAL OPINION OF THE TIF PHYSICIAN, THE ROOT CAUSE OF THE PATIENT'S OUTCOME CANNOT BE DETERMINED. IT CANNOT BE CONCLUSIVELY DETERMINED IF THE HHR PROCEDURE, TIF PROCEDURE, THE PATIENT'S UNKNOWN/UNDIAGNOSED COMORBIDITIES (INCLUDING CORONARY ARTERY DISEASE), OR A COMBINATION OF EVENTS, CONTRIBUTED TO OR CAUSED THE ADVERSE EVENT. THIS EVENT IS BEING FILED IN AN ABUNDANCE OF CAUTION DUE TO THIS UNCERTAINTY.

    Additional Manufacturer Narrative · 0

    ENDOGASTRIC SOLUTIONS REVIEWED THIS EVENT/MDR WITH DR. (B)(6), MD, WHO PROVIDED HIS MEDICAL OPINION ON THE ASSOCIATED HARM(S) WHICH SHOULD BE TRENDED FOR THIS EVENT/MDR. PER DR. (B)(6) MEDICAL OPINION, THE HEALTH EFFECT - CLINICAL CODE FIELD HAS BEEN UPDATED TO REFLECT ISCHEMIA, ESOPHAGEAL PERFORATION, AND EMPYEMA AS THE HARMS ASSOCIATED WITH THIS REPORT. AS THERE IS NO HEALTH EFFECT - CLINICAL CODE FOR DEATH, "DEATH" HAS BEEN SELECTED IN SECTION H1 ON THE 3500A FORM.

    Additional Manufacturer Narrative · 0

    A MEDWATCH INITIAL FINAL REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW OF EGS COMPLAINTS [3005473391] BY MERIT MEDICAL'S SYSTEMS INC, [1721504] PMS TEAM FOR ANY IDENTIFIED COMPLAINT DISCREPANCIES REQUIRING SUBMISSIONS, CORRECTIONS AND/OR ADDITIONAL INFORMATION PER 21 CFR 803. MERIT MEDICAL, 1600 WEST MERIT PARKWAY, SOUTH JORDAN, UT 84095, 801-253-1600. CORRECTIONS TO EGS MEDWATCH REPORT: B.7 - HISTORY UPDATED TO INCLUDE TRANSORAL INCISIONLESS FUNDOPLICATION (TIF), HIATAL HERNIAS [HH], GERD, PERFORATION. D6A - IMPLANT DATE ADDED. UPDATED G CODE TO 788. 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). PER THE PHYSICIAN, THE TIF PROCEDURE WAS COMPLETED UNEVENTFULLY AND THE ESOPHYX DEVICE PERFORMED AS INTENDED. FOLLOWING BOTH PROCEDURES, THE PATIENT REMAINED IN THE HOSPITAL AND WAS DIAGNOSED WITH CORONARY ARTERY DISEASE, ESOPHAGEAL ISCHEMIA, AND AN ESOPHAGEAL PERFORATION DURING HOSPITALIZATION. THE PATIENT UNDERWENT A CT SCAN, BARIUM SWALLOW, AND AN ESOPHAGRAM ON UNKNOWN DATES. AN ENDOSCOPY WAS PERFORMED ON AN UNKNOWN DATE TO REPAIR THE ESOPHAGEAL PERFORATION AND TO PLACE A STENT AND CHEST TUBE. PER THE PHYSICIAN, THE PATIENT PASSED AWAY SOMETIME BETWEEN (B)(6) 2023 AND (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717859 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403595 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization