BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 18381476 · Received December 22, 2023

    Report

    Report Number
    3001845648-2023-00942
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    July 19, 2022
    Report Date
    May 16, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    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. IT WAS CREATED FROM THE ATTACHED 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¿. THIS FILE CAPTURES THE OFF LABEL USE FOR SBS (SIDE-BY-SIDE PLACEMENT) IN JAPAN AND USER ERROR FOR PSIS (PARTIAL STENT-IN-STENT) PLACEMENT IN JAPAN. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL ZILBS DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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: ¿THE SAFETY AND EFFICACY OF COMBINED SIDE-BY-SIDE WITH OVERLAPPING STENTS HAS NOT BEEN ESTABLISHED." IT ALSO STATES: "THIS DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. [DOING SO COULD RESULT IN DIFFICULTY OR INABILITY TO REMOVE THE DELIVERY SYSTEM.]". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE JAPANESE PACKAGING INSERT. FROM THE INFORMATION CONTAINED IN THE PAPER IT IS KNOWN THAT THE ZILVER 635 BILIARY STENT WAS USED FOR SBS (SIDE-BY-SIDE PLACEMENT) WHICH IS OFF LABEL USE IN JAPAN. THE DEVICE WAS ALSO USED FOR PSIS (PARTIAL STENT-IN-STENT PLACEMENT) GROUPS, WHICH IS DEEMED TO BE A USE ERROR. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS DETERMINED FROM THE INVESTIGATION. FROM THE ARTICLE IT IS KNOWN THAT 2 PATIENTS UNDERWENT STENT DEPLOYMENT VIA SIDE-BY-SIDE STENTING. AS PREVIOUSLY MENTIONED, THE JAPANESE PACKAGING INSERT STATES ¿THE SAFETY AND EFFICACY OF COMBINED SIDE-BY-SIDE WITH OVERLAPPING STENTS HAS NOT BEEN ESTABLISHED.¿ AS PER (B)(4), REV006, OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. ALSO SECONDARY TO THE OFF-LABEL USE, IT IS KNOWN THAT 120 PATIENTS UNDERWENT STENT DEPLOYMENT VIA THE PSIS METHOD. AS PREVIOUSLY MENTIONED, THE JAPANESE PACKAGING INSERT STATES ¿THIS DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. [DOING SO COULD RESULT IN DIFFICULTY OR INABILITY TO REMOVE THE DELIVERY SYSTEM.]¿ USER/USE RELATED COMPLAINTS IS CONSIDERED FORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY 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 ARTICLE, 02 PATIENTS UNDERWENT STENT DEPLOYMENT VIA SIDE-BY-SIDE STENTING, 120 PATIENTS UNDERWENT STENT DEPLOYMENT VIA THE PSIS METHOD. CONFIRMED QUANTITY OF 122 DEVICE, CONFIRMED USED. THE PATIENT OUTCOMES ARE NOT CONFIRMED IN THE ARTICLE. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS DETERMINED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS.

    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. MOST OF THE PATIENTS UNDERWENT MULTIPLE SEMS DEPLOYMENT USING THE PARTIAL STENT-IN-STENT (PSIS) METHOD. 2 PATIENTS UNDERWENT STENT DEPLOYMENT VIA SIDE BY SIDE STENTING. 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 16-MAY-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297753 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male