BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER

    MDR report key: 17505361 · Received August 10, 2023

    Report

    Report Number
    3005473391-2023-00188
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    June 28, 2023
    Report Date
    March 1, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED B3: DATE OF EVENT AND B4: DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    UPDATING HEALTH EFFECT IMPACT CODE (F) TO ONLY INCLUDE: 4614, 4641, 4649, AND 4639. UPDATING TYPE OF INVESTIGATION (B) TO ONLY INCLUDE: 4115, 3331, 4112, 4109, 4110, AND 4111. UPDATING INVESTIGATION FINDINGS (C) TO ONLY INCLUDE: 3221. UPDATING INVESTIGATION CONCLUSIONS (D) TO ONLY INCLUDE: 4315.

    Additional Manufacturer Narrative · 0

    THIS MDR WAS INITIALLY FILED TO COMPLY WITH THE 21 CFR PART 803 30-DAY REPORTING REQUIREMENT DESPITE LIMITED INFORMATION PROVIDED TO EGS REGARDING THE REPORTED ADVERSE EVENT (I.E., ASPIRATION PNEUMONIA POST-TIF PROCEDURE). AS OF THE DATE OF THIS REPORT, EGS HAS NOT RECEIVED ADDITIONAL INFORMATION TO FACILITATE A DEEPER INVESTIGATION INTO THE REPORTED PATIENT ADVERSE EVENT. HOWEVER, AFTER A THOROUGH INVESTIGATION OF THE INITIAL INFORMATION AND CONSULTING WITH A HIGHLY EXPERIENCED TIF PHYSICIAN, IT WAS DETERMINED THE TIF PROCEDURE DOES NOT CONTRIBUTE TO NOR CAUSE ASPIRATION PNEUMONIA. THUS, THIS INCIDENT DOES NOT MEET FDA REPORTABILITY THRESHOLDS PER 21 CFR PART 803.

    Additional Manufacturer Narrative · 0

    CURRENTLY IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED TO ENDOGASTRIC SOLUTIONS (EGS) FOR EVALUATION. THE INVESTIGATION IS ONGOING, AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY ENDOGASTRIC SOLUTIONS, WHICH THE COMPANY HAS NOT BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Additional Manufacturer Narrative · 0

    A 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 EGS MEDWATCH REPORT: B.2 - UPDATED TO INCLUDE [X] LIFE-THREATENING EVENT. B.7 HISTORY UPDATED TO INCLUDE . GERD, HIATAL HERNIA, STRICTURES, DRAINAGE TUBES, ASPIRATION PNEUMONIA. D6A - IMPLANT DATE - ADDED. UPDATED E CODES TO INCLUDE 1735. UPDATED F CODES TO INCLUDE 4617. UPDATED A CODES TO INCLUDE 2993. UPDATED G CODE TO 788. REPLACED C CODE TO INCLUDE 3221. REPLACED D CODE TO INCLUDE 67. H.8 UPDATED TO REFLECT [X] INITIAL USE.

    Additional Manufacturer Narrative · 0

    EGS ORIGINALLY DEEMED THIS COMPLAINT AS A REPORTABLE EVENT BASED ON INFORMATION AVAILABLE AT THE TIME OF INITIAL SUBMISSION ON 10 AUGUST 2023. AFTER RECEIVING ADDITIONAL INFORMATION AND FURTHER REVIEW, EGS DEEMED THIS COMPLAINT AS NOT REPORTABLE ON 30 NOVEMBER 2023. FOLLOWING AN FDA ADDITIONAL INFORMATION INQUIRY, THIS COMPLAINT HAS NOW BEEN DEEMED REPORTABLE AND IS BEING REPORTED HEREIN. FOLLOWING ADDITIONAL REVIEW, UPDATED HEALTH EFFECT IMPACT CODE TO ADD 4621, MEDICAL DEVICE PROBLEM CODE TO ADD 2993, AND TYPE OF INVESTIGATION TO ADD 4112, 4109, AND 4110.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A HIATAL HERNIA REPAIR (HHR) PROCEDURE FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE AND A NONDESCRIPT PRODUCT MALFUNCTION AND AN ADVERSE EVENT WAS REPORTED. THE REPORTED ADVERSE EVENT IS ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072620 ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER ODE ODE ENDOGASTRIC SOLUTIONS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| L BOUGIE USE| ENDOSCOPE OLYMPUS 190