BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 9932247 · Received April 7, 2020

    Report

    Report Number
    3001845648-2020-00219
    Event Type
    Malfunction
    Date Received
    April 7, 2020
    Date of Event
    November 30, 2018
    Report Date
    December 8, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K182980. 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. DOCUMENT REVIEW 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040-6) STATES THE FOLLOWING: ¿THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. STANDARD TECHNIQUES FOR PLACEMENT OF PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE CATHETERS AND METAL STENTS SHOULD BE EMPLOYED.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE IFU WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOW THAT THE STENTS WERE USED IN CONJUNCTION WITH IODINE-125 SEED STRANDS. THERE ARE NO INSTRUCTIONS CONTAINED WITHIN THE IFU FOR USING IODINE-125 SEED STRANDS WITH THESE DEVICES. THEREFORE, THIS IS CONSIDERED TO BE OFF-LABEL USE. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT OUTCOME IN RELATION TO THE OFF-LABEL USE IS UNKNOWN. FROM THE CLINICAL INFORMATION PROVIDED IT IS THOUGHT THAT THE OFF-LABEL USE OF THE DEVICE WOULD NOT HAVE IMPACTED ON THE FUNCTIONALITY OF THE DEVICE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K182980. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    ZHOU 2018 ¿ ¿STUDY OF PERCUTANEOUS STENT PLACEMENT WITH IODINE-125 SEED STRAND FOR MALIGNANT BILIARY OBSTRUCTION¿. OFF LABEL USE: A STIFF GUIDEWIRE 260 CM LONG AND 0.035 INCHES IN DIAMETER WAS INSERTED THROUGH THE SHEATH TO THE DISTAL DUODENUM. NEXT, THE SHEATH WAS REMOVED AND REINSERTED OVER THE SHORT GUIDEWIRE UNTIL ITS TIP WAS 2¿3 CM BEYOND THE STRICTURE. A BARE SEM WAS ADVANCED OVER THE LONG GUIDEWIRE AND DEPLOYED IN THE CENTER OF THE STRICTURE. THE STENT EXTENDED 1.5¿2 CM BEYOND THE BILIARY STRICTURE IN EACH DIRECTION. AFTER STENTING, THE IODINE SEED STRAND WAS INSERTED THROUGH THE LONG 5-F SHEATH AND PLACED BETWEEN THE BILIARY WALL AND THE STENT. STENT PATENCY WAS CONFIRMED WITH REPEAT CHOLANGIOGRAPHY. THE PUNCTURE APPROACH WAS OCCLUDED WITH GELFOAM PLEDGETS THROUGH A SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395927 ZILVER BILIARY SELF-EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown