BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 15302049 · Received August 26, 2022

    Report

    Report Number
    3001845648-2022-00581
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    May 6, 2019
    Report Date
    January 13, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. 510K: K182980.

    Additional Manufacturer Narrative · 0

    510K: K182980. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PRE-EXISTING CONDITIONS. FROM THE ARTICLE IT IS KNOWN THAT 133 OF THE 134 PATIENTS HAD CANCER AT BASELINE. AS PER MEDICAL ADVISOR INPUT ¿IF THE EVENT DID NOT OCCUR DUE TO A DEVICE DEFICIENCY, IT WOULD LIKELY BE DUE TO TUMOUR INGROWTH/PRE-EXISTING CONDITION¿. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 01 PATIENT REQUIRED A CHANGE OF DRAIN DUE TO NON-PERMEABILITY OF THE BILIARY STENT, THE PATIENT RECOVERED/STABILIZED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DEVICE ISSUE ( BILIARY STENT): NON PERMEABILITY. TREATMENT: RESOLVED, ENDOSCOPIC, CHANGE OF DRAIN.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-JAN-23.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477622 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention