BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE BILIARY DRAINAGE STENT V

    MDR report key: 19566058 · Received June 19, 2024

    Report

    Report Number
    9614641-2024-01280
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    January 2, 2024
    Report Date
    July 19, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FGE
    PMA / PMN Number
    K103478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED STRAIGHT PLASTIC STENTS (PS), (PBD SERIES), OLYMPUS CHOSE THE REPRESENTATIVE MODEL AS PBD-1030-1007. THE EVALUATION OF THE EVENT IS ONGOING. ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH IS RELATED TO THE FOLLOWING 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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "BEFORE USE, INSPECT THE INSTRUMENT AS INSTRUCTED BELOW. SHOULD THE SLIGHTEST IRREGULARITY BE SUSPECTED, DO NOT USE THE INSTRUMENT; DAMAGE OR IRREGULARITY MAY COMPROMISE PATIENT SAFETY BY, FOR EXAMPLE: POSING AN INFECTION CONTROL RISK; CAUSING TISSUE IRRITATION, PERFORATION, BLEEDING, CLOGGED, MIGRATING, FALLING OFF FROM THE PAPILLA, OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO RESULT IN MORE SEVERE EQUIPMENT DAMAGE." "WHEN POSITIONING THE STENT, POSITION IT SLOWLY ALIGNED WITH BILE DUCT UNDER X-RAY. OTHERWISE, IT COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, MUCOUS MEMBRANE DAMAGE, OR MIGRATION." "AFTER PLACING THE STENT IN THE DUCT, CLOSELY MONITOR THE CONDITION OF THE PATIENT. ALSO, PERIODICALLY CHECK THE CONDITION OF THE STENT (TO SEE IF THE LUMEN OF THE STENT IS NOT CLOGGED, ETC.) AND THE CONDITION OF IMPLANTATION OF THE STENT (TO SEE IF THE POSITION OF THE STENT HAS NOT CHANGED). IN CASE OF IRREGULARITIES OR UNNECESSARY RETENTION OF THE STENT, REMOVE THE STENT USING GRASPING FORCEPS. IF NECESSARY, PERIODICALLY EXCHANGE THE STENT. THE STENT MAY DETERIORATE OVER TIME AND COULD BECOME CLOGGED. THE STATUS OF THE STENT CAN CHANGE WITH THE CONDITION OF THE PATIENT (E.G., INFLAMMATION, REMITTENCE OF BILIARY TRACT STENOSIS ETC.). THE STENT MAY DETERIORATE OVER TIME, CAUSING THE SIDE FLAP TO BREAK OR DETACH COMPLETELY (REPORTS HAVE BEEN RECEIVED ON SIDE FLAPS COMING OFF SEVERAL MONTHS AFTER PLACEMENT). DETERIORATION OR DAMAGE TO THE STENT MAY RESULT IN EROSION OF THE DUODENAL WALL, BILIARY TRACT OBSTRUCTION, DETACHMENT OF THE STENT PART MIGRATING INTO THE DUCT OR OUT OF THE PAPILLA, MUCOUS MEMBRANE DAMAGE, PERFORATION, OR BLEEDING." "THE FREQUENCY RATE FOR THE STENT DISLOCATION IS REPORTED A 3.3% TO 13.3%. IMMEDIATELY REMOVE THE STENT IF DISLOCATION IS DETECTED." "DO NOT USE THIS INSTRUMENT IN PATIENTS IN WHOM ANY METAL STENT HAS BEEN IMPLANTED. THIS INSTRUMENT MAY BE CAUGHT BY THE STENT AND CAUSES DAMAGE TO THE STENT, RESULTING IN MIGRATION AND DISLOCATION OF THE STENT." "WHEN WITHDRAWING THIS INSTRUMENT, CONFIRM UNDER X-RAY THAT THE INSERTED PART OF IT IS FREE FROM KINKS AND IS NOT STUCK IN THE STRICTURE. OTHERWISE, IT COULD CAUSE PATIENT INJURY, SUCH AS MIGRATION AND DISLOCATION OF THE STENT." "DO NOT RETRIEVE THIS INSTRUMENT IN OTHER METHODS THAN DESCRIBED IN THIS INSTRUCTION MANUAL. OTHERWISE, IT COULD CAUSE MIGRATING OR FALLING OFF FROM THE PAPILLA AND COULD DAMAGE THE INSTRUMENT." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS RECEIVED THE FOLLOWING LITERATURE TITLED "PERFORMANCE OF BILIARY STENTS IN MALIGNANT BILIARY STRICTURES." THIS RETROSPECTIVE STUDY WAS TO COMPARE THE EFFECTIVENESS OF SELF-EXPANDABLE METAL STENTS (SEMSS) AND PLASTIC STENTS (PSS) IN THE ENDOSCOPIC DRAINAGE OF MALIGNANT STRICTURES OF THE BILIARY TREE AND ITS SEQUELS FOR THE FUTURE OPTIMIZATION OF THIS TREATMENT METHOD. A TOTAL OF 618 PATIENTS WERE INCLUDED (456 IN THE PS GROUP AND 162 PATIENTS IN SEMS GROUP). IN THE PS GROUP, STRAIGHT STENTS EXHIBITED A LONGER MEDIAN PATENCY TIME THAN DPT STENTS (52 [21106] DAYS VS 34.5 [14¿73] DAYS; P = 0.001). A DECREASED MEDIAN STENT PATENCY TIME WAS OBSERVED IN THE PATIENTS WITH HIGH VS LOW OBSTRUCTION LEVEL (49 [20¿109] DAYS VS 66 [28¿136] DAYS; P = 0.003). MEDIAN (IQR) BILIRUBIN DROP WAS 37% (14%¿58%) IN THE SEMS GROUP AND 32% (9%¿53%) IN THE PS GROUP (P = 0.01). MOREOVER, THE PATIENTS IN THE SEMS GROUP SHOWED A CRP LEVEL DECREASE BY 10.5%, WHEREAS IN THE PS GROUP THE CRP LEVEL ROSE BY 17% (P = 0.02). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: ACUTE PANCREATITIS (36 CASES), LIVER ABSCESS (25 CASES), BLEEDING (24 CASES), PERFORATION (8 CASES), CHOLECYSTITIS (5 CASES), OTHER (21 CASES). DEVICE MALFUNCTION INVOLVING THE PLASTIC STENT (PS): DISTAL MIGRATION (PARTIAL) (59 CASES), PROXIMAL MIGRATION (15 CASES), COMPLETE MIGRATION (17 CASES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678745 SINGLE USE BILIARY DRAINAGE STENT V SINGLE USE BILIARY DRAINAGE STENT FGE AOMORI OLYMPUS CO., LTD. PBD-1030-1007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other DUODENOVIDEOSCOPE