BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 9933683 · Received April 7, 2020

    Report

    Report Number
    3001845648-2020-00231
    Event Type
    Malfunction
    Date Received
    April 7, 2020
    Date of Event
    July 19, 2019
    Report Date
    October 15, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K182980. DEVICE EVALUATION: THE ZIB DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENTS AND WERE NOT AVAILABLE FOR EVALUATION. DOCUMENT REVIEW: 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 THESE ZIB DEVICES COULD NOT BE PERFORMED AS THE LOT NUMBERS WERE UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0040-6). ROOT CAUSE REVIEW: 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 PATIENTS HAD MALIGNANT EXTRAHEPATIC BILIARY OBSTRUCTION DUE TO UNRESECTABLE PANCREATIC CANCER. IN ADDITION, BASED ON ALL THE POTENTIAL HARMS IDENTIFIED FORM THE RISK DOCUMENTATION PANCREATITIS HAS BEEN IDENTIFIED AS A RESIDUAL RISK. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, ALL NINE PATIENTS HAD MILD ACUTE PANCREATITIS WITHOUT LOCAL OR SYSTEMIC COMPLICATIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THIS SUPPLEMENT REPORT IS BEING SUBMITTED AS THE INVESTIGATION WAS CONCLUDED ON THE (B)(6)2021.

    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 2-3 DAYS TO EVALUATE STENT PATENCY. AMONG 31 PATIENTS WITH ELEVATED SERUM AMYLASE LEVEL MORE THAN NORMAL VALUE, NINE OF WHOM HAD NEWLY DEVELOPED ABDOMINAL PAIN. THEREFORE, THE INCIDENCE OF ACUTE PANCREATITIS WAS 6.4% (9/ 140 PATIENTS). IN TERMS OF SEVERITY GRADE, ALL NINE PATIENTS HAD MILD ACUTE PANCREATITIS WITHOUT LOCAL OR SYSTEMIC COMPLICATIONS. ABDOMINAL PAIN SUBSIDED WITH CONSERVATIVE TREATMENT AFTER A MEAN OF 2.9 DAYS (RANGE, 1-4 DAYS; ONE AT DAY 1, THREE AT DAY 2, ONE AT DAY 3, AND FOUR AT DAY 4). IN ALL 31 PATIENTS WITH HYPERAMYLASAEMIA AFTER STENT INSERTION, SERUM AMYLASE LEVELS RETURNED TO NORMAL OR PRE-STENTING LEVELS WITHIN 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396153 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 Required Intervention