BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE BILIARY DRAINAGE STENT V

    MDR report key: 18147442 · Received November 16, 2023

    Report

    Report Number
    9614641-2023-01718
    Event Type
    Injury
    Date Received
    November 16, 2023
    Report Date
    January 2, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FGE
    PMA / PMN Number
    K933200
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT. ADDITIONALLY TO PROVIDE INFORMATION RECEIVED THROUGH FOLLOW UP (DL23482472-4). THE DEVICE HISTORY RECORD WITH THE SUBJECT LOT NUMBER WAS CONFIRMED FOR THE LOTS 2YK THROUGH 3XK* SINCE THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED AND THE EVENT DATE WAS UNKNOWN. 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, IT IS POSSIBLE THAT THE STENT MAY HAVE MIGRATED INTO THE TARGET SITE DUE TO FACTORS SUCH AS BEING PUSHED TOO FAR INTO THE TARGET SITE DUE TO THE SHAPE OF THE INSERTION PORTION OF THE ENDOSCOPE OR THE CONDITION OF THE TARGET SITE WHEN THE STENT WAS PLACED. HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED FOR INVESTIGATION AND A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED WITH THE INFORMATION RECEIVED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "THIS INSTRUCTION MANUAL CONTAINS ESSENTIAL INFORMATION ON USING THIS INSTRUMENT SAFELY AND EFFECTIVELY. BEFORE USE, THOROUGHLY REVIEW THIS MANUAL AND THE MANUALS OF ALL EQUIPMENT WHICH WILL BE USED DURING THE PROCEDURE AND USE THE INSTRUMENTS AS INSTRUCTED. IF YOU HAVE ANY QUESTIONS OR COMMENTS ABOUT ANY INFORMATION IN THIS MANUAL, PLEASE CONTACT OLYMPUS." "DO NOT USE THIS INSTRUMENT IF THIS INSTRUMENT AND ITS RETENTION STATUS CANNOT BE CHECKED PERIODICALLY AFTER PLACEMENT." "AFTER PLACING A STENT, PERIODICALLY CHECK THE CONDITIONS OF THE STENT AND ITS IMPLANTATION. DEPENDING ON THE CONDITION OR INTERNAL ENVIRONMENT OF THE PATIENT BODY, MATERIAL DETERIORATION OF THE PLACED STENT OVER TIME CAN RESULT IN ANOTHER DETACHMENT OF SIDE FLAP(S). THAT POSSIBILITY IS INCREASING THE LONGER THE STENT IS PLACED IN THE DUCT." "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, AND IF THERE ARE FOUR SIDE FLAPS IN THE SIDE OF THE DUODENUM, 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." "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." "DO NOT FORCE THE INSTRUMENT IF RESISTANCE TO INSERTION IS ENCOUNTERED. REDUCE THE ANGULATION OR LOWER THE FORCEPS ELEVATOR UNTIL THE INSTRUMENT PASSES SMOOTHLY. DO NOT ADVANCE OR EXTEND THE INSTRUMENT ABRUPTLY. THESE ACTIONS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE, AND COULD DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT." "DO NOT INSERT THE STENT INTO THE PAPILLA OF VATER AND/OR BILE DUCT ABRUPTLY. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, MUCOUS MEMBRANE DAMAGE, OR COULD DAMAGE THE INSTRUMENT." "WHEN INSERTING THE INSTRUMENT, DO NOT PUSH THE STENT, THE GUIDEWIRE AND/OR THE GUIDE CATHETER INTO THE BILE DUCT EXCESSIVELY. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE." "INSERT THE INSTRUMENT INTO THE ENDOSCOPE WHILE THE FLAP AT THE PROXIMAL END OF THE STENT IS RETRACTED INSIDE THE PROTECTION SLEEVE. OTHERWISE, THE STENT COULD GET STUCK AT THE BIOPSY VALVE OR INSIDE ENDOSCOPE¿S INSTRUMENT CHANNEL AND DAMAGE THE STENT AND/OR THE ENDOSCOPE." "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." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ONE OF THE FOUR CASES WAS AN ATTEMPTED BREAK-IN AND THE STENT WAS RECOVERED. OF THE OTHER THREE CASES, ONE WAS DEFINITELY MISPLACED. THE REMAINING TWO CASES ARE UNKNOWN IF THE STENT WAS MISPLACED OR NOT. ADDITIONALLY, IT IS UNKNOWN WHETHER THE OTHER THREE STENTS WERE RECOVERED OR NOT. NO IMAGE AVAILABLE. IT IS UNKNOWN WHERE IN THE BILE DUCT THE STRICTURE OCCURRED, IF THE DEVICE MALFUNCTION OCCURRED DURING OR AFTER STENT PLACEMENT, IF FOLLOW UP OBSERVATION WAS PERFORMED, PATIENT'S CONDITION, TIME OF STENT MISPLACEMENT, OR TYPE OF MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING THE THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR BILE DUCT STENOSIS, THE SINGLE USE BILIARY DRAINAGE STENT STRAYED IN THE BILE DUCT DURING STENT REPLACEMENT. THE ORIGINALLY PLACED STENT DID NOT STRAY AND WAS RETRIEVED, BUT THE NEWLY PLACED STENT WAS PUSHED IN TOO FAR. THE PROCEDURE WAS COMPLETED BY REMOVING THE STRAY STENT AND PLACING ANOTHER ONE. THE DEVICE WAS INSPECTED BEFORE USE WITH NO DEFECTS. THERE WAS NO MAJOR IMPACT ON THE PATIENT OR PROCEDURE. THE CUSTOMER CONFIRMED THIS EVENT HAS OCCURRED ON FOUR DIFFERENT OCCASIONS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN OR NOT PROVIDED. RELATED PATIENT IDENTIFIERS: (B)(6) SINGLE USE BILIARY DRAINAGE STENT V MODEL: PBD-V631P-0805 SN: UNKNOWN. (B)(6) SINGLE USE BILIARY DRAINAGE STENT V MODEL: PBD-V631P-0805 SN: UNKNOWN. (B)(6) SINGLE USE BILIARY DRAINAGE STENT V MODEL: PBD-V631P-0805 SN: UNKNOWN. (B)(6) SINGLE USE BILIARY DRAINAGE STENT V MODEL: PBD-V631P-0805 SN: UNKNOWN. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194400 SINGLE USE BILIARY DRAINAGE STENT V SINGLE USE BILIARY STENT FGE AOMORI OLYMPUS CO., LTD. PBD-V631P-0805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention