BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 9932255 · Received April 7, 2020

    Report

    Report Number
    3001845648-2020-00222
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    November 30, 2018
    Report Date
    November 17, 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. THE INSTRUCTIONS FOR USE (IFU0040-6) 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 DEVELOPMENT OF OBSTRUCTIVE JAUNDICE. IT IS POSSIBLE THAT PATIENT PRE-EXISTING CONDITIONS MAY HAVE ALSO CONTRIBUTED TO THE EVENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, SECONDARY INTERVENTIONS WITHIN THE SEEDED GROUP INCLUDED STENT REVISION WITH A NEW STENT, EXTERNAL DRAINAGE, AND CONSERVATIVE TREATMENT BECAUSE OF LARGE ASCITES AND POOR GENERAL CONDITION. IN THE CONTROL GROUP SECONDARY INTERVENTIONS INCLUDED STENT REVISION AND EXTERNAL DRAINAGE. 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. 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. RECURRENT OBSTRUCTIVE JAUNDICE OCCURRED IN FIVE PATIENTS IN THE SEEDS GROUP AND IN FOUR PATIENTS IN THE CONTROL GROUP. IN THE SEEDS GROUP, TWO PATIENTS UNDERWENT STENT REVISION WITH A NEW STENT, TWO PATIENTS RECEIVED EXTERNAL DRAINAGE, AND ONE PATIENT RECEIVED ONLY CONSERVATIVE TREATMENT BECAUSE OF LARGE ASCITES AND POOR GENERAL CONDITION. IN THE CONTROL GROUP, STENT REVISION WAS PERFORMED IN THREE PATIENTS AND EXTERNAL DRAINAGE IN ONE PATIENT.

    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
    395935 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