BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 14758311 · Received June 21, 2022

    Report

    Report Number
    8010047-2022-10472
    Event Type
    Death
    Date Received
    June 21, 2022
    Date of Event
    May 25, 2021
    Report Date
    July 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION FROM THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND AUTHOR. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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 EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED ¿BILIARY SELF-EXPANDABLE METAL STENT COULD BE RECOMMENDED AS A FIRST TREATMENT MODALITY FOR IMMEDIATE REFRACTORY POST-ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY BLEEDING¿, PATIENTS EXPERIENCED ADVERSE EVENTS DURING/AFTER PROCEDURES AN OLYMPUS DUODENOSCOPE. COMPLAINT WITH PATIENT IDENTIFIER C22207144 REPORTS ONE PATIENT. COMPLAINT WITH PATIENT IDENTIFIER C22207145 REPORTS ONE PATIENT. COMPLAINT WITH PATIENT IDENTIFIER C22207146 REPORTS THE REMAINING PATIENTS EXPERIENCING AE BACKGROUND/AIMS. RECENT REPORTS SUGGEST THAT THE BILIARY SELF-EXPANDABLE METALLIC STENT (SEMS) IS HIGHLY EFFECTIVE FOR MAINTAINING HEMOSTASIS WHEN ENDOSCOPIC HEMOSTASIS FAILS IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)-RELATED BLEEDING. WE COMPARED WHETHER TEMPORARY SEMS OFFERS BETTER EFFICACY THAN ANGIOEMBOLIZATION FOR REFRACTORY IMMEDIATE ERCP-RELATED BLEEDING. METHODS PATIENTS WHO UNDERWENT SEMS PLACEMENT OR UNDERWENT ANGIOEMBOLIZATION FOR BLEEDING CONTROL IN REFRACTORY IMMEDIATE ERCP-RELATED BLEEDING WERE INCLUDED IN THE RETROSPECTIVE ANALYSIS. WE EVALUATED THE HEMOSTASIS SUCCESS RATE, SEVERITY OF BLEEDING, CHANGE IN HEMOGLOBIN LEVELS, AMOUNT OF TRANSFUSION, AND DELAY TO THE START OF HEMOSTASIS. RESULTS A TOTAL OF 27 PATIENTS WITH SEMS AND 13 PATIENTS WHO UNDERWENT ANGIOEMBOLIZATION WERE ENROLLED. MORE TRANSFUSIONS WERE NEEDED IN THE ANGIOEMBOLIZATION GROUP (1.0±1.4 UNITS VS. 2.5±2.0 UNITS; P=0.034). SEMS FAILURE WAS SUCCESSFULLY RESCUED BY ANGIOEMBOLIZATION. THE PARTIALLY COVERED SEMS (N=23, 85.1%) WAS GENERALLY USED, AND THE MEDIAN STENT-INDWELLING TIME WAS 4 DAYS. THE MEAN DELAY TO THE START OF ANGIOEMBOLIZATION WAS 95.2±142.9 (RANGE, 9¿491) MIN. CONCLUSIONS TEMPORARY SEMS HAD SIMILAR RESULTS TO THOSE OF ANGIOEMBOLIZATION (96.3% VS. 92.3%; P=0.588). IMMEDIATE SEMS INSERTION IS CONSIDERED A BRIDGE TREATMENT MODALITY FOR IMMEDIATE REFRACTORY ERCP-RELATED BLEEDING. ANGIOEMBOLIZATION STILL HAS A ROLE AS RESCUE THERAPY WHEN SEMS DOES NOT WORK EFFECTIVELY. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY. THERE WAS ONE CASE OF SEMS FAILURE, AND ANGIOEMBOLIZATION WAS PERFORMED FOR RESCUE THERAPY AFTER SEMS DEPLOYMENT. AN 89-YEAR-OLD MAN WITH A CHARLSON COMORBIDITY INDEX OF 4 HAD NO RISK FACTORS FOR BLEEDING TENDENCY UNDERWENT ERCP FOR A CBD STONE. ACTIVE OOZING PERSISTED AFTER SEMS PLACEMENT, ANGIOEMBOLIZATION WAS SUCCESSFULLY PERFORMED TO ACHIEVE HEMOSTASIS. A 74-YEAR-OLD MALE PATIENT WITH A CHARLSON COMORBIDITY INDEX OF 5 UNDERWENT INITIAL ERCP BECAUSE OF SUSPECTED HILAR CHOLANGIOCARCINOMA AT AN OUTSIDE HOSPITAL AND WAS TRANSFERRED TO OUR HOSPITAL FOR ANGIOEMBOLIZATION. THE TIME BETWEEN THE INITIAL ERCP AND ANGIOEMBOLIZATION WAS 6 H AND 18 MIN. THIS CASE WAS THE ONLY MORTALITY IN OUR STUDY, DESPITE PERFORMING ANGIOEMBOLIZATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: IN THE MEDICAL OPINION OF THE AUTHOR, THE OLYMPUS DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THIS LITERATURE. THE AUTHOR STATED THERE WAS NO OLYMPUS DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546835 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Death