BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 9549072 · Received January 3, 2020

    Report

    Report Number
    3001845648-2020-00006
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 28, 2017
    Report Date
    October 21, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. 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 ¿BILOMA¿ 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. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE PROCEDURE. AS PER MEDICAL ADVISOR INPUT ¿HEMOBILIA AND BILOMAS WERE PERCUTANEOUS PROCEDURE RELATED COMPLICATIONS REGARDLESS OF THE STENT TYPE I.E., COVERED OR UNCOVERED¿. IT SHOULD ALSO BE NOTED THAT THE IFU LISTS BILOMA AS A POTENTIAL ADVERSE EVENT. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER SHIM ET AL ¿PERCUTANEOUS METALLIC STENT PLACEMENT FOR PALLIATIVE MANAGEMENT OF MALIGNANT BILIARY HILAR OBSTRUCTION¿. ACCORDING TO THE INITIAL REPORTER, 10 PATIENTS DEVELOPED BILOMAS THAT REQUIRED PERCUTANEOUS DRAINAGE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    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. FROM THE INFORMATION PROVIDED IN THIS ARTICLE IT IS KNOWN THAT A NUMBER OF UNCOVERED STENTS FROM VARIOUS MANUFACTURER'S WERE USED DURING THIS STUDY INCLUDING ZILVER STENTS (COOK MEDICAL), SENTINOL STENTS (BOSTON SCIENTIFIC) AND NITI S STENTS (TAEWOOG MEDICAL). 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 ZILBS 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 (IFU0065-3) LISTS TRAUMA TO THE BILIARY TRACT OR DUODENUM AS A KNOWN POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER 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 INJURY OF THE BILE DUCT DURING THE PROCEDURE. HOWEVER, AS A NUMBER OF MANUFACTURER¿S STENTS WERE USED DURING THIS STUDY AND AS THE LITERATURE ARTICLE DOES NOT DETAIL WHICH STENT THIS ADVERSE EVENT RELATES TO, IT CANNOT BE CONFIRMED THAT THE COOK STENT CAUSED AND/OR CONTRIBUTED TO THIS EVENT. AS THE INFORMATION RECEIVED IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT IT WAS THE COOK STENT THAT CONTRIBUTED TO THE EVENT, RISK WILL NOT BE COMPLETED. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 10 PATIENTS DEVELOPED BILOMAS THAT REQUIRED PERCUTANEOUS DRAINAGE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE DEVICE NAME AND INVESTIGATION.

    Description of Event or Problem · 0

    SHIM - PERCUTANEOUS METALLIC STENT PLACEMENT FOR PALLIATIVE MANAGEMENT OF MALIGNANT BILIARY HILAR OBSTRUCTION. MAJOR COMPLICATIONS OCCURRED IN 25 PATIENTS (6%). BILOMAS THAT REQUIRED PERCUTANEOUS DRAINAGE IN 10 PATIENTS.

    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. MAJOR COMPLICATIONS OCCURRED IN 25 PATIENTS (6%). BILOMAS THAT REQUIRED PERCUTANEOUS DRAINAGE IN 10 PATIENTS. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS THE PATIENTS DEVELOPED BILOMAS AND REQUIRED PERCUTANEOUS DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11759 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention