BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 20042259 · Received August 22, 2024

    Report

    Report Number
    3005473391-2024-00231
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K240879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR MORE ROBUST DEVICE CODING AND USE OF ANNEX A AS REQUESTED BY THE FDA. MERIT MEDICAL SYSTEMS INC. (B)(6). CORRECTIONS/ADDITIONS AND OR EDITS TO THIS MEDWATCH REPORT: UPDATED A CODES TO INCLUDE 1250,1384, 1670 AND 3002.

    Additional Manufacturer Narrative · 0

    THE ALLEGED SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE RESULTED IN NO NON CONFORMANCES WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. SHOULD THE DEVICE BE AT A LATER DATE, THE INVESTIGATION WILL BE REOPENED

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A HIATAL HERNIA REPAIR (HHR) PROCEDURE FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. AT LEAST ONE BOUGIE WAS USED PRIOR TO THE INSERTION OF THE ESOPHYX DEVICE TO DILATE THE ESOPHAGUS. DURING THE TIF PROCEDURE, PER THE PHYSICIAN, THERE WAS DIFFICULTY DISENGAGING THE HELIX FROM TISSUE AT ONE PLACEMENT SITE. ONCE THE HELIX WAS DISENGAGED FROM THE TISSUE AT THE PLACEMENT SITE, SOME TISSUE WAS NOTED REMAINING IN THE HELIX COIL AND A BLEED, NOT REQUIRING TRANSFUSION WAS NOTED AT THE HELIX PLACEMENT SITE. THE PHYSICIAN ATTEMPTED TO CONTINUE THE PROCEDURE AND NOTED DIFFICULTY ENGAGING THE HELIX AT OTHER PLACEMENT SITES WITH THE NOTED TISSUE REMAINING IN THE COIL. ADDITIONALLY, THE PHYSICIAN NOTED IMPACTS TO VISIBILITY DUE TO THE BLEED AND DECIDED TO REMOVE THE ESOPHYX DEVICE. THE PHYSICIAN INSERTED AN ENDOSCOPE AND INJECTED EPINEPHRINE AT THE BLEEDING SITE. ADDITIONALLY, SEVEN HEMOSTATIC CLIPS WERE PLACED NEAR THE BLEEDING SITE, HOWEVER THE NOTED BLEEDING CONTINUED. PURA-STAT WAS APPLIED TO THE DISTAL ESOPHAGUS AT THE Z-LINE AND A COVERED ESOPHAGEAL STENT WAS PLACED IN THE DISTAL ESOPHAGUS. PER THE PHYSICIAN, THERE MAY HAVE BEEN MUSCULARIS TISSUE WHICH WAS REMOVED AND REMAINED IN THE HELICAL COIL OF THE ESOPHYX DEVICE. PER THE PHYSICIAN, NO PERFORATION WAS SEEN, AND THE COVERED STENT WAS PLACED AS A PRECAUTION. THE PATIENT REPORTEDLY REMAINED STABLE THROUGHOUT THE PROCEDURE WITH NO CHANGE IN VITAL SIGNS. THE PHYSICIAN IS REPORTEDLY PLANNING TO BRING THE PATIENT BACK AT A LATER DATE TO FINISH THE TIF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741739 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403651 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| L| H