BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 18377896 · Received December 21, 2023

    Report

    Report Number
    3001845648-2023-00943
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    July 19, 2022
    Report Date
    March 11, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K182980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 JOURNAL ARTICLE REF. ATT. ¿MATSUMOTO - 2022 (003).PDF¿. 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 C-ES1207M06 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. THIS STATES THE FOLLOWING: ¿¿3) AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOR SHRINKAGE, STENT EROSION OF THE TISSUE, AND/OR MUCOSAL BLEEDING.¿ THERE IS 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 OF THE USER NOT READING OR FOLLOWING THE JAPANESE PACKAGING INSERT HAS BEEN CONCLUDED. FROM THE ARTICLE IT IS KNOWN THAT 81 PATIENTS RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT. AS PREVIOUSLY MENTIONED, THE JAPANESE PACKAGING INSERT STATES ¿AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOR SHRINKAGE, STENT EROSION OF THE TISSUE, AND/OR MUCOSAL BLEEDING¿. 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 MATSUMOTO ET AL 2022 ¿COMPARISON OF BILATERAL AND TRISEGMENT DRAINAGE IN PATIENTS WITH HIGH-GRADE HILAR MALIGNANT BILIARY OBSTRUCTION: A MULTICENTER RETROSPECTIVE STUDY¿. ACCORDING TO THE INITIAL REPORTER, 81 PATIENTS RECEIVED CHEMOTHERAPY AFTER STENT PLACEMENT, NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THIS OCCURRENCE. INVESTIGATION FINDING CONCLUDE A DEFINITIVE ROOT CAUSE OF USER ERROR. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION ON 11-MAR-2025 AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT (COMPLAINT DID NOT GO AGAINST THE STEPS OUTLINED IN THE IFU FOR THE SAFE & CORRECT USE OF THE DEVICE. ADVISING ''AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING.). FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    MATSUMOTO, 2022¿ COMPARISON OF BILATERAL AND TRISEGMENT DRAINAGE IN PATIENTS WITH HIGH-GRADE HILAR MALIGNANT BILIARY OBSTRUCTION: A MULTICENTER RETROSPECTIVE STUDY. THIS STUDY USED THE FOLLOWING SEMSS: 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., TOKYO, JAPAN), NITI-S BILIARY STENT (TAEWOONG MEDICAL CO., GIMPO, KOREA), AND BILERUSH SELECTIVE (PIOLAX, KANAGAWA, JAPAN). BILATERAL (LEFT HEPATIC DUCT AND THE ANTERIOR BRANCH OF THE RIGHT HEPATIC DUCT OR POSTERIOR BRANCH OF THE RIGHT HEPATIC DUCT) OR BILATERAL WITH TRISEGMENT (LEFT HEPATIC DUCT, ANTERIOR BRANCH OF THE RIGHT HEPATIC DUCT, AND POSTERIOR BRANCH OF THE RIGHT HEPATIC DUCT) DRAINAGE WERE PERFORMED DEPENDING ON THE PHYSICIAN¿S DISCRETION. MOST OF THE PATIENTS UNDERWENT MULTIPLE SEMS DEPLOYMENT USING THE PARTIAL STENT-IN-STENT (PSIS) METHOD. HYBRID AND SIDE-BY-SIDE METHODS WERE ALSO PERFORMED BASED ON PREVIOUS REPORTS. PATIENTS RECEIVED CHEMOTHERPY AFTER STENT PLACEMENT 25 BILATERAL DRAINAGE GROUP AND 56 TRISEGMENT DRAINAGE GROUP. PATIENT OUTCOME: NOT CONFIRMED IN THE ARTICLE. PATIENT/EVENT INFO: BILATERAL DRAINAGE GROUP: AVERAGE AGE 76, 16 MALE/20 FEMALES TRISEGMENT DRAINAGE GROUP: AVERAGE AGE 75, 51 MALE/38 FEMALES".

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 17-MAY-2024.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING RECEIPT OF CONFIRMATION FROM THE QUALITY ENGINEER ON 11-MAR-2025 THAT THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT SINCE THE COMPLAINT DID NOT GO AGAINST THE STEPS OUTLINED IN THE IFU FOR THE SAFE & CORRECT USE OF THE DEVICE. ADVISING ''AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING. FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034239 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