BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 19069581 · Received April 9, 2024

    Report

    Report Number
    3001845648-2024-00153
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    June 21, 2023
    Report Date
    August 21, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4). IT WAS CREATED FROM THE ATTACHED LITERATURE PAPER OKUNO ET AL 2023 ¿UTILITY OF BILATERAL INTRADUCTAL PLASTIC STENT FOR MALIGNANT HILAR BILIARY OBSTRUCTION COMPARED WITH BILATERAL SELF-EXPANDABLE METAL STENT: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS. THIS FILE CAPTURES 05 CASES OF CHOLECYSTITIS. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL ZILBS DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/OR LABEL. THE JAPANESE PACKAGING INSERT (B)(4) 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 JAPANESE PACKAGING INSERT STATES: "1) POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: (3) CHOLECYSTITIS. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE JAPANESE PACKAGING INSERT. IMAGE REVIEW. AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE WOULD LIKELY BE ATTRIBUTED TO THE PATIENTS PRE-EXISTING CONDITIONS OR TO KNOWN POTENTIAL COMPLICATIONS OF THE PROCEDURE. FROM THE INFORMATION PROVIDED, THE PRE-EXISTING CONDITION FOR PATIENTS INVOLVED IN THE STUDY WAS MALIGNANT HILAR BILIARY OBSTRUCTION (UMHBO). ETIOLOGY OF UMHBO IN THE STUDY INCLUDES BILIARY TRACT CANCER, METASTASIS OF PANCREATIC CANCER, COLON CANCER, AND GASTRIC CANCER. AS PREVIOUSLY NOTED, CHOLECYSTITIS IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU/ JAPANESE PACKAGING INSERT. CONFIRMATION OF COMPLAINT. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS. SUMMARY THE COMPLAINT WAS RAISED FROM LITERATURE PAPER OKUNO ET AL 2023 ¿UTILITY OF BILATERAL INTRADUCTAL PLASTIC STENT FOR MALIGNANT HILAR BILIARY OBSTRUCTION COMPARED WITH BILATERAL SELF-EXPANDABLE METAL STENT: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS. THIS FILE CAPTURES (B)(4) CASES OF CHOLECYSTITIS. CONFIRMED QTY OF (B)(4), CONFIRMED USED. ACCORDING TO THE ATTACHED PAPER, (B)(4) CASES OF CHOLECYSTITIS WERE SUCCESSFULLY MANAGED WITH PERCUTANEOUS DRAINAGE. PER MEDICAL ADVISOR INPUT, ALL CHOLECYSTITIS CASES WOULD HAVE REQUIRED INTERVENTION/ADDITIONAL PROCEDURES (B)(4). CHOLECYSTITIS CASES WERE SUCCESSFULLY MANAGED WITH PERCUTANEOUS DRAINAGE. INVESTIGATION FINDING CONCLUDE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE WOULD LIKELY BE ATTRIBUTED TO THE PATIENTS PRE-EXISTING CONDITIONS OR TO KNOWN POTENTIAL COMPLICATIONS OF THE PROCEDURE. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS.

    Description of Event or Problem · 0

    (B)(6) 2023 - UTILITY OF BILATERAL INTRADUCTAL PLASTIC STENT FOR MALIGNANT HILAR BILIARY OBSTRUCTION COMPARED WITH BILATERAL SELF-EXPANDABLE METAL STENT: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS. BILATERAL TRANSPAPILLARY STENT PLACEMENT WAS PERFORMED USING A STANDARD DUODENOSCOPE (TJF-200, JF-240, JF-260V, OR TJF-260V; OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN). AFTER CHOLANGIOGRAPHY, A GUIDEWIRE (.025-INCH VISIGLIDE2 [OLYMPUS MEDICAL SYSTEM SYSTEM], .025-INCH ENDOSELECTOR [BOSTON SCIENTIFIC JAPAN, TOKYO, JAPAN]; OR .025-INCH M-THROUGHTM [ASAHI INTECC, AICHI, JAPAN]) WAS INSERTED INTO THE INTRAHEPATIC BILE DUCT (IHBD). PATIENTS UNDERWENT ENDOSCOPIC SPHINCTEROTOMY (ES) AFTER PLACING THE GUIDEWIRE ON THE OPPOSITE SIDE OF THE IHBD, IF NECESSARY. BILATERAL SEMS PLACEMENT WAS PERFORMED BY 1 OF 2 METHODS, THE ¿STENT-IN-STENT¿ (SIS) AND ¿SIDE-BY-SIDE¿ (SBS) TECHNIQUES. IN THE SIS PLACEMENTMETHOD, THE FIRST UNCOVERED SEMS WAS DEPLOYED ACROSS THE CONFLUENCE ON 1 SIDE OF THE IHBD. THE GUIDEWIRE WAS ACCESSED ON THE OPPOSITE SIDE OF THE IHBD THROUGH THE FIRST SEMS MESH, AND THE SECOND UNCOVERED SEMS WAS DEPLOYED THROUGH THE FIRST SEMS (FIG. 1B). BECAUSE THIS WAS A RETROSPECTIVE STUDY, THE VARIOUS TYPES OF SEMS USED FOR SIS PLACEMENT WERE AS FOLLOWS: NITI-S LARGE CELL D-TYPE BILIARY STENT (TEAWOONG, SEOUL, KOREA), BONASTENT M-HILAR (STANDARD SCI-TECH, SEOUL, KOREA), HILZO STENT (BCM CO, LTD, GYEONGGI-DO, SOUTH KOREA), BILERUSH (PIOLAX MEDICAL DEVICES, YOKOHAMA, JAPAN), ZILVER 635 STENT (COOK MEDICAL, BLOOMINGTON, IND, USA), ZEO STENT (ZEON MEDICAL INC, TOKYO, JAPAN), AND JOSTENT SELFX STENT (ABBOTT- VASCULAR DEVICES, TEMECULA, CALIF, USA). FOR SBS PLACEMENT, THE 2 UNCOVERED SEMS DELIVERY CATHETERS WERE INSERTED INTO THE BILATERAL IHBDS, AND BOTH SEMSS WERE PLACED (FIG. 1C). THE SEMS TYPES USED FOR SBS PLACEMENT WERE BILERUSH, ZILVER 635 STENT, AND HANAROSTENT (MI TECH, SEOUL, KOREA). THE SEMSS WERE DIVIDED INTO BRAIDED (NITI-S, NONASTENT, HILZO, ANDHANAROSTENT) AND LASER-CUT (BILERUSH, ZILVER, ZEO, AND JOSTENT) TYPES. ALL SEMS DIAMETERS WERE 8 OR 10MM. THE LENGTHS OF THE ISS AND SEMSSWERE DETERMINED BY THE MAIN OPERATORS, CONSIDERING THE MALIGNANT BILIARY OBSTRUCTION (MBO) LENGTH AND DISTAL COMMON BILE DUCT. 5 CASES OF CHOLECYSTITIS CASES WERE SUCCESSFULLY MANAGED WITH PERCUTANEOUS DRAINAGE. TEMPORARY ENBD PLACEMENT: WAS PERFORMED IN IN 12 CASES (63%) IN THE SEMS GROUP. PATIENT OUTCOME: REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 06-SEP-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309915 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention