BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 14578270 · Received June 2, 2022

    Report

    Report Number
    8010047-2022-09299
    Event Type
    Death
    Date Received
    June 2, 2022
    Date of Event
    July 18, 2021
    Report Date
    July 13, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. 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 BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: D4, D8, H6, H10. 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 ARTICLE TITLED:¿ ENDOSCOPIC INTERNAL DRAINAGE OF COMPLEX BILOMAS AND BILIARY LEAKS BY TRANSMURAL OR TRANSPAPILLARY/TRANSFISTULARY ACCESS,¿ PATIENT EXPERIENCED ADVERSE EVENTS DURING AND AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GF-UCT140-AL5 (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GF-UCT140-AL5 (FOR ADVERSE EVENTS OTHER THAN DEATH). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TGF-UC180J (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TGF-UC180J (FOR ADVERSE EVENTS OTHER THAN DEATH). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-160VR (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-160VR (FOR ADVERSE EVENTS OTHER THAN DEATH). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-Q180V (FOR DEATH OF PATIENTS). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-Q180V (FOR ADVERSE EVENTS OTHER THAN DEATH). STUDY BACKGROUND AND AIM: BILOMAS MOST FREQUENTLY RESULT FROM POSTOPERATIVE BILE LEAKS. THE ENDOSCOPIC CONVENTIONAL TREATMENT IS SPHINCTEROTOMY STENT PLACEMENT. IN COMPLEX CASES, SUCH AS ALTERED ANATOMY OR FAILURE OF CONVENTIONAL TREATMENT, TRANSPAPILLARY/TRANSFISTULARY (TP/TF) DRAINAGE OR EUS-GUIDED TRANSMURAL DRAINAGE (EUS-TD) MAY OBVIATE ADDITIONAL BILIARY SURGERY. THIS STUDY REPORTS OUR EXPERIENCE WITH TREATING BILOMA SECONDARY TO REFRACTORY BILIARY LEAK WITH TP/TF DRAINAGE OR EUS-TD AND EVALUATES THE SAFETY AND OUTCOMES ASSOCIATED WITH THIS APPROACH. METHODS: THIS OBSERVATIONAL STUDY FOCUSED ON CONSECUTIVE PATIENTS MANAGED FOR BILIARY LEAKAGE (DIAGNOSIS BASED ON IMAGING AND/OR BILE OUTFLOW FROM A SURGICAL DRAIN) AT A TERTIARY CARE HOSPITAL (2007-2017). TP/TF DRAINAGE WAS PERFORMED BY DOUBLE-PIGTAIL STENT(S) PLACEMENT TO DRAIN THE BILOMA THROUGH THE LEAK DURING ERCP. FOR EUS-TD, PLASTIC STENT(S) WERE PLACED UNDER EUS CONTROL. PRIMARY OUTCOMES WERE A COMPOSITE OF CLINICAL SUCCESS (PATIENT FREE OF SEPSIS AFTER PERCUTANEOUS DRAIN REMOVAL AND, IN PATIENTS WITH BENIGN DISEASE, REMOVAL OF ALL ENDOSCOPICALLY PLACED STENTS, WITHOUT NEED FOR REINTERVENTION) AND BILOMA REGRESSION (<3CM) AT LAST FOLLOW-UP. RESULTS: THIRTY PATIENTS (MEN, 57%; MEDIAN AGE, 55 YEARS) WERE INCLUDED. MOST BILIARY LEAKS RESULTED FROM CHOLE CYSTECTOMY (27%) AND HEPATECTOMY (50%). INITIAL EUS-TD AND TP/TF DRAINAGE WERE PERFORMED IN 14 (47%) AND 16 (53%) PATIENTS, RESPECTIVELY. AT LAST FOLLOW-UP (MEDIAN, 33.2 MONTHS), CLINICAL SUCCESS AND PRIMARY OUTCOME WERE ACHIEVED IN 70.4% OF PATIENTS (EUS-TD, 75%; TP/TF, 67%). ADDITIONAL SURGERY WAS NECESSARY IN 1 PATIENT. RATE OF SERIOUS ADVERSE EVENTS WAS 23% (7/30), OF WHICH 13% (4/30) WERE PROCEDURE RELATED. THERE WERE 4 DEATHS DURING THE COURSE OF TREATMENT, 2 OF WHICH WERE RELATED TO ENDOSCOPIC INTERVENTIONS (HEMORRHAGE AND FIBRILLATION). CONCLUSIONS: TP/TF DRAINAGE OR EUS-TD IS TECHNICALLY FEASIBLE WITH HIGH CLINICAL SUCCESS AND MAY AVOID THE NEED FOR ADDITIONAL SURGERY IN COMPLEX CASES OR IN PATIENTS WITH ALTERED ANATOMY. EFFICACY MONITORING WAS AVAILABLE FOR 27 PATIENTS AND UN AVAILABLE BECAUSE OF DEATH DURING ENDOSCOPIC TREATMENT PERIOD IN 3 PATIENTS (2 BECAUSE OF ENDOSCOPIC TREATMENT¿S ADVERSE EVENT AND 1 BECAUSE OF LEAKAGE AND SEPTIC SHOCK). THE MEDIAN LENGTH OF FOLLOW-UP WAS 33.2 MONTHS. AMONG THESE 27 PATIENTS, 2 HAD A REDO PERCUTANEOUS DRAINAGE AND 1 HAD A REDO SURGERY. AFTER TREATMENT OF COMPLEX BILIARY LEAK, 6 PATIENTS (25%) DEVELOPED SECONDARY BILIARY STRICTURES THAT RESOLVED AFTER ENDOSCOPIC MULTIPLE PLASTIC STENT PLACEMENT TREATMENT IN THE FOLLOWING MONTHS. TEN OF 30 PATIENTS (33%): 2 AFTER THE UNDERLYING ENDOSCOPIC TREATMENT FROM SEPTIC SHOCK ASSOCIATED WITH THE BILIARY LEAK (INCLUDING 1 PATIENT WHO DIED 6 YEARS AFTER THE REMOVAL OF THE PIGTAIL STENTS 6 MONTHS AFTER THEIR PLACEMENT, WHICH HAD ALLOWED THE CLOSURE OF THE BILIARY LEAK), 1 FROM SEPTIC SHOCK DURING A FURTHER BILIARY STRICTURE STENT PLACEMENT PROCEDURE, AND 5 FROM CANCER PROGRESSION. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION REPORTED IN ANY PROCEDURE DESCRIBED IN THIS LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161437 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death