BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 13891546 · Received March 24, 2022

    Report

    Report Number
    3001845648-2022-00177
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    October 21, 2019
    Report Date
    April 8, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    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 UNKNOWN DEVICE OF 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. THE INVESTIGATION FOR THIS FILE HAS BEEN BASED ON A ZIB DEVICE AS IT IS KNOWN THAT A COOK BILIARY STENT WAS USED DURING THE PROCEDURES MENTIONED IN THE ARTICLE. AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0040-6). A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. ACCORDING TO THE LITERATURE PAPER AND THE DESCRIPTION OF EVENT IODINE SEED STRAND WAS RELEASED BETWEEN THE SEMS AND BILE DUCT WALL WHICH IS CONSIDERED OFF LABEL USE. IT IS NOT POSSIBLE TO STATE HOW THE DEVICE WILL PERFORM WHEN USED OUTSIDE OF ITS VALIDATED STATE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 6 PATIENTS EXPERIENCED ASYMPTOMATIC AMYLASE INCREASE AND 4 PATIENTS EXPERIENCED SELF-LIMITED BILIARY HAEMORRHAGE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ZHOU ET AL 2019 ¿ ¿BILIARY SELF-EXPANDABLE METALLIC STENT COMBINED WITH IODINE-125 SEEDS STRAND IN THE TREATMENT OF HILAR MALIGNANT BILIARY OBSTRUCTION¿. SEED GROUP (OFF LABEL USE): THE 125I SEEDS STRAND, USED FOR LOADING THE SEEDS, WAS MADE BY INSERTING THE APPROPRIATE NUMBER OF 125I SEEDS INTO A 4F CATHETER (COOK MEDICAL, BLOOMINGTON, IN, USA) THAT WAS THEN HEAT SEALED AT EITHER END. SEMS AND 125I SEEDS STRAND IMPLANTATION: TWO HYDROPHILIC WIRES WERE ARRANGED ACROSS THE BILE DUCT STRICTURE. THE SEMS (COOK IRELAND), USUALLY 8 OR 10 MM IN DIAMETER AND 40¿100 MM IN LENGTH (ZIB6), WAS DEPLOYED VIA ONE WIRE. A 6F GUIDING CATHETER (COOK MEDICAL), USED FOR 125I SEED DEPLOYMENT, WAS INSERTED VIA THE OTHER WIRE. AFTER THE STENT WAS RELEASED, A PREPARED 125I SEEDS STRAND WAS INSERTED INTO THE 6F GUIDING CATHETER AND LOCATED AT THE BILE DUCT STENO-SIS. WHILE WITHDRAWING THE 6F GUIDING CATHETER, THE I SEEDS STRAND WAS RELEASED BETWEEN THE SEMS AND BILE DUCT WALL. FINALLY, A 7.0¿8.5F DRAINAGE CATHETER (COOK INC) WAS PLACED INDWELLING ABOVE THE SEMS. CONTROL GROUP: 36 PATIENTS (40 DEVICES) RECEIVED SEMS ONLY (ZIB6). OFF LABEL USE: IODINE SEED STRAND RELEASED BETWEEN THE SEMS AND BILE DUCT WALL. PATIENT OUTCOMES: 6 PATIENTS EXPERIENCED ASYMPTOMATIC AMYLASE INCREASE. 4 PATIENTS EXPERIENCED SELF-LIMITED BILIARY HAEMORRHAGE.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986791 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male