BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 20372021 · Received October 4, 2024

    Report

    Report Number
    9610595-2024-20124
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    August 6, 2020
    Report Date
    November 15, 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

    H6 HEALTH EFFECT - CLINICAL CODE 4581 - APPROPRIATE TERM / CODE NOT AVAILABLE IS USED TO REFLECT DELAYED GASTRIC EMPTYING. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MDR IS BEING SUBMITTED FOR EVENT 1. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONALLY, TO PROVIDE AN UPDATE TO FIELDS (B5 AND D8) AND TO PROVIDE A CORRECTION TO FIELD (E1). 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 FOLLOWING LITERATURE TITLED "COMPARISON OF DOUBLE-LAYER LARGE-DIAMETER AND CONVENTIONAL SMALL-DIAMETER PLASTIC STENTS FOR PREOPERATIVE BILIARY DRAINAGE IN RESECTABLE DISTAL MALIGNANT BILIARY OBSTRUCTION." LITERATURE SUMMARY: THE USE OF A PLASTIC STENT (PS) IN RESECTABLE PATIENTS WITH DISTAL MALIGNANT BILIARY OBSTRUCTION (DMBO) IS UNCOMMON DUE TO THE HIGH FAILURE RATE OF THIS METHOD. THIS STUDY EVALUATED THE EFFICACY AND SAFETY OF A DOUBLE-LAYER, LARGE-DIAMETER PS AS A BRIDGE TO SURGERY COMPARED WITH A CONVENTIONAL PS. THIS WAS A SINGLE-CENTER RETROSPECTIVE COHORT STUDY. IN TOTAL, 129 CONSECUTIVE PATIENTS WITH DMBO UNDERWENT PANCREATICODUODENECTOMY BETWEEN (B)(6) 2011 AND (B)(6) 2018. FIFTY-FIVE PATIENTS WHO PREOPERATIVELY UNDERWENT PLASTIC BILIARY DRAINAGE WERE ENROLLED. THE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON STENT DIAMETER: A LARGE-DIAMETER PLASTIC STENT (LPS) GROUP AND A SMALL-DIAMETER PLASTIC STENT (SPS) GROUP. THE PRIMARY ENDPOINT WAS THE STENT PATENCY PERIOD, AND THE SECONDARY ENDPOINT WAS THE MEDICAL COST. THIRTY-SIX PATIENTS RECEIVED SPSS; 19 PATIENTS RECEIVED LPSS. THE PATENCY RATE UNTIL SURGERY WAS SIGNIFICANTLY HIGHER IN THE LPS GROUP THAN IN THE SPS GROUP (89.5% VS. 41.7%, P = 0.0006). MULTIVARIATE ANALYSIS REVEALED THAT LPS USE WAS SIGNIFICANTLY ASSOCIATED WITH SUFFICIENT STENT PATENCY. THE TOTAL COST OF LPS USE WAS SIGNIFICANTLY LOWER THAN THAT OF SPS USE. LPSS HAD LONGER PATENCY AND REDUCED MEDICAL COSTS THAN SPSS. LPSS MAY BE SUITABLE FOR PATIENTS WITH DMBO WHO ARE SCHEDULED TO UNDERGO SURGERY. MATERIALS AND METHODS: THE LPS GROUP RECEIVED A 10-FR DLS (DOUBLE-LAYER STENT, OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN). STENT PLACEMENT COMPLICATIONS AND STENT DYSFUNCTION. REGARDING THE COMPLICATIONS RELATED TO STENT PLACEMENT, FOUR PATIENTS EXPERIENCED MILD PANCREATITIS: 3 PATIENTS (8%) RECEIVED AN SPS, AND ONE PATIENT RECEIVED AN LPS (9%). HOWEVER, ACCORDING TO THE JAPANESE GUIDELINES FOR THE MANAGEMENT OF ACUTE PANCREATITIS, NO SEVERE ERCP-RELATED PANCREATITIS DEVELOPED. STENT DYSFUNCTION BEFORE SURGERY OCCURRED IN A TOTAL OF 23 PATIENTS. THE PATENCY RATE OF THE LPS GROUP WAS SIGNIFICANTLY HIGHER THAN THAT OF THE SPS GROUP (89.5% VS. 41.7%, P =0.0006). THE MEDIAN NUMBER OF STENT DYSFUNCTION EVENTS WAS 0 IN THE LPS GROUP AND 1 IN THE SPS GROUP, FOR A SIGNIFICANTLY LOWER RATE IN THE LPS GROUP THAN IN THE SPS GROUP (P=0.0034). THE KAPLAN¿MEIER CURVE ALSO SHOWED THAT STENT PATENCY WAS SIGNIFICANTLY LONGER IN THE LPS GROUP THAN IN THE SPS GROUP. SPECIFICALLY, THE 41-DAY STENT PATENCY RATE (AS STATED, 41 DAYS WAS THE MEDIAN INTERVAL TIME TO SURGERY AT OUR INSTITUTION) WAS HIGHER IN THE LPS GROUP THAN IN THE SPS GROUP (89% VS. 46%, P =0.0034) (FIG. 2). THE CAUSE OF STENT DYSFUNCTION IN THE LPS GROUP INCLUDED MIGRATION OF THE STENT (ONE PATIENT) AND OCCLUSION OF THE STENT WITH JAUNDICE (ONE PATIENT); THE CASE WITH MIGRATION INVOLVED IMPACTION AT THE CYSTIC DUCT. TYPE OF EVENTS/NUMBER OF PATIENTS: EVENT 1: SERIOUS ADVERSE EVENTS, POSTOPERATIVE COMPLICATION, PRESENT - 7 PATIENTS, ALL INFECTION COMPLICATIONS - 5 PATIENTS, SURGICAL SITE INFECTION - 2 PATIENTS, CHOLANGITIS - 1 PATIENT, PANCREATIC FISTULA - 3 PATIENTS, DELAYED GASTRIC EMPTYING - 2 PATIENTS. STENT PLACEMENT COMPLICATIONS: PANCREATITIS (1 PATIENT). EVENT 2: MALFUNCTION WITH SERIOUS ADVERSE EVENTS: STENT MIGRATION WITH IMPACTION AT THE STENT DUCT (1 PATIENT), STENT OCCLUSION WITH JAUNDICE (1 PATIENT).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE AUTHOR THAT THE RISK OF COMPLICATIONS WAS LOW OR NOT SIGNIFICANTLY DIFFERENT FROM THE CONTROL STENT. IT IS UNLIKELY THAT THE OLYMPUS DEVICE CAUSED (OR WAS RELATED TO) THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325146 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other FLEXIMA BILIARY STENT, BOSTON SCIENTIFIC| PBD-1030-1010/UNKNOWN LOT NO.| ZIMMON BILIARY STENT, COOK