BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 9932254 · Received April 7, 2020

    Report

    Report Number
    3001845648-2020-00221
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    November 30, 2018
    Report Date
    November 18, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040-6) STATES THE FOLLOWING: ¿THE STENT HAS NOT BEEN DESIGNED TO INHIBIT TUMOR INGROWTH. TISSUE MAY GROW THROUGH STENTS.¿. THE IFU DOES NOT CONTAIN ANY INFORMATION REGARDING THE USE OF BRACHYTHERAPY SEEDS (IODINE125 SEED STRANDS) WITH THIS DEVICE NOR HAS THE DEVICE BEEN TESTED FOR USE WITH SUCH COMPONENTS AND SO THE POTENTIAL IMPACT ON THE FUNCTIONALITY OF THE DEVICE IS NOT KNOWN. IT IS THEREFORE CONSIDERED OFF-LABEL USE THAT THE DEVICE WAS USED WITH THE IODINE125 SEED STRANDS. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE USE OF IODINE125 SEED STRANDS WITH THE DEVICE. AS THE DEVICE HAS NOT BEEN TESTED FOR USE WITH IODINE125 SEED STRANDS THE POTENTIAL EFFECTS OF THE SEED STRAND ON THE DEVICE ARE UNKNOWN. IT IS POSSIBLE THAT THE OFF-LABEL USE OF THE DEVICE RESULTED IN THE STENT BECOMING OCCLUDED. IT SHOULD ALSO BE NOTED THAT THE IFU STATES THAT THE STENT IS NOT DESIGNED TO INHIBIT TUMOR INGROWTH AND SO TISSUE MAY GROW THROUGH THE STENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENT REQUIRED AN ADDITIONAL STENT AS A RESULT OF THIS EVENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE COMPLAINT INVESTIGATION BEING COMPLETED ON 18-NOV-2020. 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.

    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
    395934 ZILVER BILIARY SELF-EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention