BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 15812618 · Received November 17, 2022

    Report

    Report Number
    3001845648-2022-00772
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Report Date
    February 22, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    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 PR 380433, PR 380437 AND PR 380438 AND IT WAS CREATED FROM THE JOURNAL ARTICLE REF. ATT. ¿ABDALLAH ET AL 2022¿. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW; PRIOR TO DISTRIBUTION ALL ZILBS-635-10-6 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0065) STATES THE FOLLOWING: ¿THE DELIVERY SYSTEM ACCEPTS A 0.035 INCH WIRE GUIDE¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE IFU CAN BE CONCLUDED. THE IFU STATES ¿¿THE DELIVERY SYSTEM ACCEPTS A 0.035 INCH WIRE GUIDE¿ HOWEVER FROM THE INFORMATION PROVIDED THE DEVICE WAS USED WITH A 0.025 INCH WIRE GUIDE. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER ABDALLAH ET AL ¿QUADRUPLE, 4-SEGMENT, TRIPLE SECTOR ¿Y-SHAPED STENTS¿ IN COMPLEX HILAR CHOLANGIOCARCINOMA AFTER CHOLANGITIS FROM PLASTIC STENTS¿. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ABDALLAH ET AL 2022 - QUADRUPLE, 4-SEGMENT, TRIPLE SECTOR ¿Y-SHAPED STENTS¿ IN COMPLEX HILAR CHOLANGIOCARCINOMA AFTER CHOLANGITIS FROM PLASTIC STENTS IN THIS CASE, WE EXPANDED UPON THE Y-SHAPED INTRADUCTAL STENT-IN-STENT TECHNIQUE, SUCCESSFULLY COMPLETING A TRIPLE Y-SHAPED CONFIGURATION. ALL BILIARY SECTORAL BRANCHES THAT PREVIOUSLY HOUSED PLASTIC STENTS WERE EXCHANGED FOR SEMSS TO PREVENT FUTURE EPISODES OF CHOLANGITIS FROM OCCURRING IN THE PREVIOUSLY INSTRUMENTED SECTORS. ALL 4 DUCTS WERE CANNULATED WITH A GUIDEWIRE, FACILITATED BY USING A STEERABLE CATHETER (SWINGTIP) BEFORE THE DEPLOYMENT OF ANY SEMS TO GUIDE INSERTION OF SUBSEQUENT SEMSS. ALL SEMSS WERE INSERTED SUPRAPAPILLARY BECAUSE SUPRAPAPILLARY PLACEMENT IS ASSOCIATED WITH LONGER STENT PATENCY, LOWER RISK OF CHOLANGITIS (FROM PRESUMED ENTERIC-BILIARY REFLUX), AND DECREASED RISK OF PANCREATITIS (FROM PANCREATIC DUCT ORIFICE COMPRESSION), COMPARED WITH TRANSPAPILLARY SEMS INSERTION. FOUR-WEEK FOLLOW-UP REVEALED NORMALIZATION OF TOTAL BILIRUBIN, ALANINE TRANSAMINASE, AND ASPARTATE TRANSAMINASE AND A SIGNIFICANT DECREASE IN ALKALINE PHOSPHATASE LEVELS WITHOUT CHOLANGITIS, WITH CT SHOWING STABLE SEMS POSITION. THE PATIENT ELECTED NOT TO PURSUE FURTHER THERAPY AND TRANSITIONED TO HOME HOSPICE CARE. A TOTAL OF FOUR 0.025-INCH 450-CM STRAIGHT GUIDEWIRES (VISIGLIDE; OLYMPUS AMERICA) WERE PASSED INTO EACH OF THE 4 SEGMENTAL INTRAHEPATIC DUCTS FROM WHICH THE 4 PLASTIC STENTS WERE JUST REMOVED. ZILBS STENT PLACED THROUGH PREVIOUS PLACED STENT A 10-MM 6-CM UNCOVERED ZILVER 635 SEMS WAS ADVANCED OVER THE WIRE, PASSING THROUGH THE SLIT IN LL-III SEMS AND INTO LL-II, FORMING A Y-SHAPED INTRADUCTAL STENT-IN-STENT THIS COMPLAINT WAS OPENED TO CAPTURE THE USE OF THE INCORRECT WIREGUIDE WITH THE ZILBS-635-10-6 DEVICE. AS PER IFU0065-4 "THE DELIVERY SYSTEM ACCEPTS A 0.035 INCH WIRE GUIDE". NO KNOWN ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 22-FEB-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182835 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 70 YR Female