BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 9548993 · Received January 3, 2020

    Report

    Report Number
    3001845648-2020-00007
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 28, 2017
    Report Date
    April 7, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K182980. DEVICE EVALUATION THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. 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.¿ THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. 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 AVAILABLE IT IS KNOWN THAT THE STENT OCCLUSION RESULTED FROM TUMOR INGROWTH. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, PATIENTS WERE MANAGED USING SEVERAL DIFFERENT TYPES OF INTERVENTIONS. THESE INCLUDED EXTERNAL DRAINAGE CATHETERS, PLACEMENT OF ADDITIONAL STENTS AND ENDOSCOPIC NASOBILIARY CATHETERS. INTERVENTIONS VARIED DEPENDING ON THE INDIVIDUAL CASE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SHIM - PERCUTANEOUS METALLIC STENT PLACEMENT FOR PALLIATIVE MANAGEMENT OF MALIGNANT BILIARY HILAR OBSTRUCTION. STENT OCCLUSION: UNCOVERED STENT DYSFUNCTION WAS CAUSED BY TUMOR INGROWTH (N = 102), SLUDGE INCRUSTATION (N = 1), TUMOR OVERGROWTH (N = 1), SEVERE KINKING OF THE COMMON BILE DUCT JUST DISTAL TO THE STENT (N = 1) AND FOOD IMPACTION (N= 1).

    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

    SHIM PERCUTANEOUS METALLIC STENT PLACEMENT FOR PALLIATIVE MANAGEMENT OF MALIGNANT BILIARY HILAR OBSTRUCTION. STENT OCCLUSION: UNCOVERED STENT DYSFUNCTION WAS CAUSED BY TUMOR INGROWTH (N = 102), SLUDGE INCRUSTATION (N = 1), TUMOR OVERGROWTH (N = 1), SEVERE KINKING OF THE COMMON BILE DUCT JUST DISTAL TO THE STENT (N = 1) AND FOOD IMPACTION (N= 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11409 ZILVER 635 SELF-EXPANDING BILIARY STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention