BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 19806187 · Received July 23, 2024

    Report

    Report Number
    3001845648-2024-00404
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Report Date
    September 6, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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. THIS FILE WAS CREATED FROM PMCF STUDY TO CAPTURE USER ERROR. STENT DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. 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. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. DEVICE EVALUATION: THE ZILBS DEVICE OF UNKNOWN RPN AND UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL ZILVER 635 BILIARY SELF EXPANDING METAL STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. INSTRUCTIONS FOR USE/LABEL IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0065) STATES THE FOLLOWING: ¿THIS DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. FROM THE AVAILABLE INFORMATION, IT IS KNOWN THAT THE STENT WAS BEING PLACED THROUGH THE SIDE WALL OF A PREVIOUSLY PLACED STENT. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU/LABEL. FROM THE AVAILABLE INFORMATION, IT IS KNOWN THAT THE STENT WAS BEING PLACED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. AS PREVIOUS MENTIONED THE IFU STATES ¿THIS DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT¿. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY: ACCORDING TO THE INITIAL REPORTER, THIS COMPLAINT WAS OPENED TO CAPTURE IDENTIFIED USER ERROR USE OF THE BILIARY STENT: MDR-20102 POST-MARKET CLINICAL FOLLOW-UP (PMCF) STUDY. STENT DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. CONFIRMED QUANTITY OF 4 DEVICES, CONFIRMED USED. THERE WAS NO INFORMATION ON PATIENT OUTCOME PROVIDED IN THE STUDY COMPLAINT FORM. INVESTIGATION FINDINGS CONCLUDE THAT THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU/LABEL. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS: GLOBAL CLINICAL NUMBER: (B)(4). TITLE OF CLINICAL STUDY: ZILVER 635 BILIARY STENT (ZILBS) FINAL REPORT. DEVICE NAME: ZILVER 635 BILIARY STENT (ZILBS). THE PRIMARY AIM OF THIS POST-MARKET CLINICAL FOLLOW-UP (PMCF) STUDY IS TO CONFIRM THE PERFORMANCE AND SAFETY OF THE BILIARY STENT AND TO ASSESS IF THE BENEFIT-RISK RATIO REMAINS FAVOURABLE. THIS WAS A RETROSPECTIVE, OBSERVATIONAL, MULTI-CENTER, POST-MARKET STUDY THAT COLLECTED DATA FROM EXISTING DATABASES (E.G., MEDICAL RECORDS, PATIENT CHARTS) FOR CONSECUTIVE PATIENTS WHO UNDERWENT STENT PLACEMENT WITH THE ZILVER 635 STENT FROM CALENDAR YEAR 2014 THROUGH 2019 AT PARTICIPATING CLINICAL SITES IN THE UNITED STATES OF AMERICA (USA). A TOTAL OF 136 PATIENT DATASETS WERE ENTERED INTO THE STUDY DATABASE AND ARE INCLUDED IN THIS FINAL REPORT. A TOTAL OF 170 BILIARY STENTS WERE PLACED OR ATTEMPTED TO BE PLACED IN 136 PATIENTS. MOST PATIENTS RECEIVED ONE STENT (79.4%,108/136). THE MOST FREQUENTLY USED STENTS WERE THE ZILBS-635-10-8 (69 STENTS). THIS COMPLAINT WAS OPENED TO CAPTURE IDENTIFIED USER ERROR USE OF THE BILIARY STENT: STENT DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT (4/136). NO INFORMATION ON PATIENT OUTCOME. THE 136 ENROLLED PATIENTS AVERAGE 67.5 YEARS OLD AVERAGE BODY MASS INDEX OF 25.2KG/M2. FEMALE 49.3% (67/136) MALE 50.7% (69/136).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906456 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 67 YR Female