BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 15311012 · Received August 29, 2022

    Report

    Report Number
    3001845648-2022-00593
    Event Type
    Injury
    Date Received
    August 29, 2022
    Report Date
    December 16, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) # 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. LAB EVALUATION ¿ N/A 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) LISTS SEPSIS AS A POTENTIAL ADVERSE EVENT. 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. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH STENT PLACEMENT PROCEDURE WAS DETERMINED. AS PER MEDICAL ADVISOR INPUT ¿SEPSIS IS NOT AN UNCOMMON COMPLICATION IN PERCUTANEOUS BILIARY PROCEDURE¿. IT SHOULD BE NOTED THE THE IFU LISTS SEPSIS AS A POTENTIAL ADVERSE EVENT. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM THE ATTACHED POST-MARKET CLINICAL STUDY ¿ZILVER 635 BILIARY SELF-EXPANDING METAL STENT & STENT SETS¿. ACCORDING TO THE INITIAL REPORTER, 05 PATIENTS DEVELOPED BILIARY SEPSIS. AS PER MEDICAL ADVISOR INPUT ¿THREE PATIENTS ALREADY HAD SEPSIS SYMPTOMS (2 SEPSIS AND 1 SEPTIC SHOCK) PRIOR TO THE PROCEDURE. IT WAS LIKELY THAT ONLY 2 SEPSIS DEVELOPED POST STENT PLACEMENT PROCEDURE¿. MEDICAL INTERVENTION WOULD HAVE BEEN REQUIRED IN 2 CASES AS A RESULT OF SEPSIS, AS PER MEDICAL ADVISOR INPUT, 'REQUIRE INTERVENTION/ADDITIONAL PROCEDURES'. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    INFECTIONS AND INFESTATIONS: BILIARY SEPSIS (5 DEVICES).

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO UPDATES TO EVENT DESCRIPTION. INFECTIONS AND INFESTATIONS: BILIARY SEPSIS (2 DEVICES).

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE 16-DEC-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373925 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 Unknown Required Intervention