BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 19068979 · Received April 9, 2024

    Report

    Report Number
    3001845648-2024-00148
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    September 19, 2023
    Report Date
    June 7, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 90 X ZIMMON BILIARY STENT DEVICES OF UNKNOWN RPN AND LOT NUMBER WERE NOT RETURNED TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. FILE RELATED TO: (B)(4) - OFF LABEL USE AND USER ERROR / MDR REF#3001845648-2024-00149, (B)(4) - PANCREATITIS, (B)(4) - ACUTE CHOLECYSTITIS / MDR REF#3001845648-2024-00150 (B)(4) - STENT KINKING. LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENTS REVIEW PRIOR TO DISTRIBUTION ALL ZIMMON BILIARY STENTS ARE SUBJECTED TO VISUAL AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE IN CIRL. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA NOT REVIEWED AS LOT NUMBER IS UNKNOWN. THE JAPANESE PACKAGING INSERT (C-ES0202M18) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. THE INSTRUCTIONS FOR USE, IFU0045 WHICH ACCOMPANIES THIS DEVICE ADVISES THE USER ON THE INTENDED USE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0045) STATES THE FOLLOWING: ¿THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS. DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE ATTRIBUTED TO STENTS BEING INSERTED INTO THE LUMEN OF EACH PREVIOUSLY DEPLOYED SEMS. THESE STENTS ARE INTENDED TO BE SOLELY USED FOR THE DRAINAGE OF OBSTRUCTED BILIARY DUCTS, USAGE OF THE DEVICE OUTSIDE OF THE INTENDED USE CAN LEAD TO OUTCOMES THAT CANNOT BE PREDICTED. AS PER THE DEVICE IFU, THE USER IS ADVISED TO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE SUMMARY: FAILURE IDENTIFIED: OFF LABEL USE. CONFIRMED QUANTITY OF 90 DEVICE CONFIRMED USED. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE ATTRIBUTED TO STENTS BEING INSERTED INTO THE LUMEN OF EACH PREVIOUSLY DEPLOYED SEMS. THESE STENTS ARE INTENDED TO BE SOLELY USED FOR THE DRAINAGE OF OBSTRUCTED BILIARY DUCTS, USAGE OF THE DEVICE OUTSIDE OF THE INTENDED USE CAN LEAD TO OUTCOMES THAT CANNOT BE PREDICTED. AS PER THE DEVICE IFU, THE USER IS ADVISED TO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER/OR REP TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    MORIMOTO 2023 - OPTIMAL LIVER DRAINAGE RATE FOR SURVIVAL IN PATIENTS WITH UNRESECTABLE MALIGNANT HILAR BILIARY OBSTRUCTION USING 3D-IMAGE VOLUME ANALYZER ALL PATIENTS UNDERWENT THE PROCEDURE VIA A STANDARD ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TECHNIQUE USING A STANDARD DUODENOSCOPE (TJF-260, TJF-240, JF-260, OR JF-260V; OLYMPUS OPTICAL CO. LTD., SHINJUKU, JAPAN) UNDER INTRAVENOUS SEDATION WITH MEPERIDINE HYDROCHLORIDE AND BENZODIAZEPINES. ALL PATIENTS UNDERWENT INITIAL ENDOSCOPIC BILIARY DRAINAGE WITH PLASTIC STENTS (PSS), AND SEMSS WERE REPLACED WITHIN 4 WEEKS AFTER A DEFINITIVE DIAGNOSIS OF MALIGNANCY. THE FOLLOWING SEMSS WERE USED: JOSTENT SELFX UNITS (ABBOTT VASCULAR DEVICES, REDWOOD CITY, CA, USA), ZILVER STENT (COOK MEDICAL, WINSTON-SALEM, NC, USA), ZEO STENT/ ZEO STENT V (ZEON MEDICAL INC., CHIYODA-KU, JAPAN), NITI-S BILIARY STENT (TAEWOONG MEDICAL CO., GIMPO-SI, KOREA), AND BILERUSH SELECTIVE (PIOLAX, YOKOHAMA, JAPAN). ALL PATIENTS UNDERWENT MORE THAN TWO SEMS DEPLOYMENTS USING THE PARTIAL STENT-IN-STENT METHOD,16 AND 8-MM OR 10-MM DIAMETER SEMSS WERE USED DEPENDING ON BILE DUCT DIAMETER. ENDOSCOPIC SPHINCTEROTOMY (EST) WAS PERFORMED TO FACILITATE ENDOSCOPIC REINTERVENTION FOR RECURRENT BILIARY OBSTRUCTION (RBO) REGARDING REINTERVENTION, AFTER CONFIRMING TUMOR INGROWTH/OVERGROWTH, SLUDGE, OR HEMORRHAGE AS THE CAUSE OF RBO, 6F OR 7F PSS INCLUDING THE TTM (GADELIUS MEDICAL, MINATO-KU, JAPAN), FLEXIMA (BOSTON SCIENTIFIC, NATICK, MA, USA), AND ZIMMON-TYPE (COOK ENDOSCOPY, WINSTON- SALEM, NC, USA) STENTS WERE INSERTED INTO THE LUMEN OF EACH PREVIOUSLY DEPLOYED SEMS PATIENT/EVENT INFO - NOTES: GENDER MALE/ FEMALE: 50/40 AGE MEDIAN YEARS: 70

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 07-JUN-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237848 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male