BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 18531679 · Received January 17, 2024

    Report

    Report Number
    9610595-2024-01097
    Event Type
    Death
    Date Received
    January 17, 2024
    Date of Event
    September 26, 2023
    Report Date
    March 13, 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 DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. DOI.ORG/10.1007/S00464-023-10457-4 PROVIDED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE LITERATURE TITLED "THE EVALUATION OF BILATERAL STENTING USING BRAIDED OR LASER-CUT SELF-EXPANDABLE METALLIC STENT FOR MALIGNANT HILAR BILIARY OBSTRUCTION." THIS RETROSPECTIVE STUDY AIMS TO EVALUATE THE DIFFERENCES IN CLINICAL FEATURES AND THE PROPER USE OF LASER-CUT AND BRAIDED SELF-EXPANDABLE METALLIC STENT (SEMS) PLACEMENTS USING THE STENT-IN-STENT (SIS) METHOD, INCLUDING ENDOSCOPIC REINTERVENTION (ERI), FOR UNRESECTABLE MALIGNANT HILAR BILIARY OBSTRUCTION (UMHBO). A TOTAL OF 78 PATIENTS WERE INCLUDED, 33 IN LASER CUT SEMS AND 45 IN BRAIDED SEMS GROUP. TECHNICAL SUCCESS WAS ACHIEVED IN 32 OF 33 CASES (97.0%) IN THE LASER-CUT GROUP AND IN 43 OF 45 CASES (95.6%) IN THE BRAIDED GROUP (P=1.0). NO SIGNIFICANT DIFFERENCE IN THE CLINICAL SUCCESS RATE WAS NOTED BETWEEN THE TWO GROUPS [LASER-CUT GROUP: 97.0% (32/33); BRAIDED GROUP: 95.6% (43/45), P=1.0]. THE CLINICAL SUCCESS OF ERI WAS ACHIEVED IN ALL TECHNICALLY SUCCESSFUL ERI CASES IN BOTH GROUPS. NO SIGNIFICANT DIFFERENCE IN THE CLINICAL SUCCESS RATE WAS DETECTED BETWEEN THE TWO GROUPS [LASER-CUT GROUP: 60.0% (9/15); BRAIDED GROUP: 85.0% (17/20), P=1.0]. BASED ON THESE RESULTS, THE MEDIAN PROCEDURE TIME OF ERI WAS SIGNIFICANTLY LONGER IN THE LASER CUT GROUP [38 (IQR 22¿55) MINUTES] THAN IN THE BRAIDED GROUP [22 (IQR 19¿37) MINUTES] (P=0.02). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PANCREATITIS (4), CHOLECYSTITIS (10), DEATH (UNKNOWN - NOT SPECIFIED). ALL POST-ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PANCREATITIS (PEP) WERE SUCCESSFULLY MANAGED CONSERVATIVELY AND CHOLECYSTITIS WAS SUCCESSFULLY MANAGED WITH PERCUTANEOUS DRAINAGE. RELATED PATIENT IDENTIFIERS: (ADVERSE EVENTS): (B)(6) EVIS DUODENOVIDEOSCOPE (TJF-200), (B)(6) EVIS DUODENOVIDEOSCOPE (JF-240), (B)(6) EVIS LUCERA DUODENOVIDEOSCOPE (TJF-260V). (DEATHS): (B)(6) EVIS DUODENOVIDEOSCOPE (TJF-200), (B)(6) EVIS DUODENOVIDEOSCOPE (JF-240), (B)(6) EVIS LUCERA DUODENOVIDEOSCOPE (TJF-260V). THERE WERE NO REPORTS OF ANY OLYMPUS DEVICE MALFUNCTION WITHIN THIS STUDY. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868581 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SINGLE USE GUIDEWIRE (G-260-2527A)