BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 9931415 · Received April 6, 2020

    Report

    Report Number
    3001845648-2020-00232
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    July 19, 2019
    Report Date
    August 21, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K182980 CUSTOMER ENTITY: DEPARTMENT OF RADIOLOGY, HANYANG UNIVERSITY GURI HOSPITAL, GURI-SI, GYEONGGI-DO, REPUBLIC OF KOREA AND DEPARTMENT OF RADIOLOGY, ASAN MEDICAL CENTER, UNIVERSITY OF ULSAN COLLEGE OF MEDICINE, SEOUL, SONGPA-GU, REPUBLIC OF KOREA THE ZIB DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. 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. A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZIB DEVICE COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THE STENT HAS NOT BEEN DESIGNED TO INHIBIT TUMOR INGROWTH. TISSUE MAY GROW THROUGH STENTS.¿ THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENT HAD MALIGNANT EXTRAHEPATIC BILIARY OBSTRUCTION DUE TO UNRESECTABLE PANCREATIC CANCER. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, RECURRENT HAEMOBILIA OCCURRED IN FIVE PATIENTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    KIM 2019 ¿ ¿ACUTE PANCREATITIS AFTER PERCUTANEOUS INSERTION OF METALLIC BILIARY STENTS IN PATIENTS WITH UNRESECTABLE PANCREATIC CANCER¿. THE ENDOPROSTHESIS WAS INTRODUCED OVER A 0.035 INCH, 150 CM LONG HYDROPHILIC GUIDEWIRE (TERUMO, TOKYO, JAPAN) OR 180 CM LONG EXTRA-STIFF AMPLATZ GUIDEWIRE (COOK) AND THEN DEPLOYED ACROSS THE STRICTURE IN ORDER TO COVER THE BILE DUCT APPROXIMATELY 2 CM DISTAL AND PROXIMAL TO THE OBSTRUCTION TO PREVENT TUMOUR OVER-GROWTH. AS ALL LESIONS WERE LOCATED WITHIN 3 CM OF THE DUODENAL PAPILLA, THE DISTAL PORTION OF THE STENT WAS PLACED JUST ABOVE THE PAPILLA OR ACROSS THE PAPILLA TO BRIDGE THE DUODENUM. POST-STENTING BALLOON DILATATION WAS NOT PER-FORMED. BOTH UNCOVERED STENTS (SENTINOL, BOSTON SCIENTI-FIC; OR ZILVER, COOK) AND COVERED STENTS (HERCULES, S&G BIOTECH, SEONGNAM, KOREA; COMVI, TAEWOONG MEDICAL, GIMPO, KOREA; OR GWON DOUBLE, TAEWOONG MEDICAL) WERE UTILISED. AFTER STENT INSERTION, A TEMPORARY DRAINAGE CATHETER WAS INSERTED JUST PROXIMAL TO STENT. PRIOR TO CATHETER REMOVAL, THE TEMPORARY DRAINAGE CATHETER WAS CLAMPED AND LEFT IN PLACE FOR 2E3 DAYS TO EVALUATE STENT PATENCY. THE DRAINAGE CATHETER COULD NOT BE REMOVED DUE TO IMMEDIATE STENT DYSFUNCTION DUE TO RECURRENT HAEMOBILIA (N=2).

    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

    KIM 2019 ¿ ¿ACUTE PANCREATITIS AFTER PERCUTANEOUS INSERTION OF METALLIC BILIARY STENTS IN PATIENTS WITH UNRESECTABLE PANCREATIC CANCER¿. THE ENDOPROSTHESIS WAS INTRODUCED OVER A 0.035 INCH, 150 CM LONG HYDROPHILIC GUIDEWIRE (TERUMO, TOKYO, JAPAN) OR 180 CM LONG EXTRA-STIFF AMPLATZ GUIDEWIRE (COOK) AND THEN DEPLOYED ACROSS THE STRICTURE IN ORDER TO COVER THE BILE DUCT APPROXIMATELY 2 CM DISTAL AND PROXIMAL TO THE OBSTRUCTION TO PREVENT TUMOUR OVER-GROWTH. AS ALL LESIONS WERE LOCATED WITHIN 3 CM OF THE DUODENAL PAPILLA, THE DISTAL PORTION OF THE STENT WAS PLACED JUST ABOVE THE PAPILLA OR ACROSS THE PAPILLA TO BRIDGE THE DUODENUM. POST-STENTING BALLOON DILATATION WAS NOT PER-FORMED. BOTH UNCOVERED STENTS (SENTINOL, BOSTON SCIENTI-FIC; OR ZILVER, COOK) AND COVERED STENTS (HERCULES, S&G BIOTECH, SEONGNAM, KOREA; COMVI, TAEWOONG MEDICAL, GIMPO, KOREA; OR GWON DOUBLE, TAEWOONG MEDICAL) WERE UTILISED. AFTER STENT INSERTION, A TEMPORARY DRAINAGE CATHETER WAS INSERTED JUST PROXIMAL TO STENT. PRIOR TO CATHETER REMOVAL, THE TEMPORARY DRAINAGE CATHETER WAS CLAMPED AND LEFT IN PLACE FOR 2E3 DAYS TO EVALUATE STENT PATENCY. THE DRAINAGE CATHETER COULD NOT BE REMOVED DUE TO IMMEDIATE STENT DYSFUNCTION DUE TO RECURRENT HAEMOBILIA (N=2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392729 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