BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 20189068 · Received September 11, 2024

    Report

    Report Number
    9610595-2024-18136
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    July 15, 2024
    Report Date
    November 1, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONALLY, TO PROVIDE A CORRECTION TO FIELD (G2) AND TO PROVIDE AN UPDATE TO FIELDS (B5 AND D8). THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THAT THE SERIAL NUMBER OF THE SUBJECT DEVICE WAS EITHER 2111076 OR 2111086. THEREFORE, D4 HAS BEEN LEFT BLANK ACCORDINGLY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UNILATERAL DRAINAGE AND CHEMOTHERAPY PROLONG THE PATENCY OF A PLASTIC STENT PLACED ABOVE THE SPHINCTER OF ODDI IN PATIENTS WITH MALIGNANT HILAR BILIARY OBSTRUCTION.". ABSTRACT OBJECTIVES TO EVALUATE THE RESULTS OF INSIDE STENT THERAPY FOR UNRESECTABLE MALIGNANT HILAR BILIARY OBSTRUCTION AND IDENTIFY FACTORS RELATED TO STENT PATENCY DURATION. METHODS OF 44 PATIENTS WHO UNDERWENT INITIAL INSIDE-STENT PLACEMENT ABOVE THE SPHINCTER OF ODDI FROM APRIL 2017 TO DECEMBER 2022, 42 WITH THE RESOLUTION OF JAUNDICE (CLINICAL SUCCESS RATE, 95.5%) WERE RETROSPECTIVELY ANALYZED. UNIVARIATE AND MULTIVARIATE LOGISTIC REGRESSION ANALYSIS IDENTIFIED FACTORS ASSOCIATED WITH STENT PATENCY DURATION. RESULTS. UNIVARIATE ANALYSIS REVEALED SIGNIFICANT DIFFERENCES IN THE DRAINAGE METHOD (406 DAYS FOR UNILATERAL DRAINAGE VS. 305 DAYS FOR BILATERAL DRAINAGE OF THE RIGHT AND LEFT LIVER LOBES, P = 0.022) WITH OR WITHOUT CHEMOTHERAPY (406 DAYS WITH VS. 154 DAYS WITHOUT, P = 0.038). MULTIVARIATE ANALYSIS (COX PROPORTIONAL HAZARDS ANALYSIS) REVEALED SIMILAR RESULTS, WITH UNILATERAL DRAINAGE (P = 0.031) AND CHEMOTHERAPY (P = 0.048) IDENTIFIED AS INDEPENDENT FACTORS ASSOCIATED WITH PROLONGED STENT PATENCY. EARLY ADVERSE EVENTS WERE OBSERVED IN TWO PATIENTS (4.8%; ONE CHOLANGITIS, ONE PANCREATITIS). ADVERSE EVENTS (AES). EARLY AES WERE OBSERVED IN TWO PATIENTS (4.8%; CHOLANGITIS, ONE; PANCREATITIS, ONE). INSIDE-STENT DYSFUNCTION WAS OBSERVED IN 14 PATIENTS (33.3%; OBSTRUCTION, 11; MIGRATION, 3) DURING THE FOLLOW-UP PERIODS. REINTERVENTION COULD BE PERFORMED WITH STENT REPLACEMENT VIA ERCP FOR 13 OF THE 14 CASES OF RBO. IN THE REMAINING CASE, ERCP WAS ATTEMPTED BUT DISCONTINUED BECAUSE OF ESOPHAGEAL VARICES. CONCLUSIONS. INSIDE-STENT THERAPY WAS SAFELY PERFORMED IN PATIENTS WITH MALIGNANT HILAR BILIARY OBSTRUCTION. SIMPLE UNILATERAL DRAINAGE AND CHEMOTHERAPY MAY PROLONG STENT PATENCY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: CHOLANGITIS (1). PANCREATITIS (1).

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556541 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other BILIARY PLASTIC STENT (GADELIUS MEDICAL CO. LTD.).