BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 18381125 · Received December 22, 2023

    Report

    Report Number
    3001845648-2023-00945
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    July 19, 2022
    Report Date
    July 1, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. DEVICE NAME CORRECTED. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. 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. THIS FILE IS RELATED TO (B)(6) (3001845648-2023-00942) , (B)(6) (3001845648-2023-00943), (B)(6) (3001845648-2023-00944). MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL ZILBS 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. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/OR LABEL: THE JAPANESE PACKAGING INSERT C-ES1207M06 SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. THE JAPANESE PACKAGING INSERT STATES THE FOLLOWING: ADDITIONAL COMPLICATIONS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO (5) STENT OCCLUSION, (6) TUMOR INGROWTH, (7) EXCESSIVE HYPERPLASTIC TISSUE INGROWTH, (8) TUMOR OVERGROWTH. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE JAPANESE PACKAGING INSERT. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE WOULD LIKELY BE ATTRIBUTED TO THE PATIENTS PRE EXISTING CONDITIONS. FROM THE PAPER, IT IS KNOWN THAT ALL PATIENTS HAD EITHER CHOLANGIOCARCINOMA (BILE DUCT CANCER) , GALLBLADDER CANCER OR ANOTHER UNSPECIFIED PRIMARY DISEASE. THE OBSTRUCTION DUE TO INGROWTH AND OVERGROWTH WAS LIKELY AS RESULT OF DISEASE PROGRESSION. ALONG WITH THE PATIENTS PRE EXISTING CONDITIONS, ANOTHER POSSIBLE ROOT CAUSE FOR THE SLUDGE COULD BE ATTRIBUTED TO THE USE OF MULTIPLE STENTS AS THE OVERLAP BETWEEN THE STENTS HAS BEEN CONSIDERED TO CREATE A MORE COMPLEX AND DENSE BILE DUCT LUMEN WHICH REDUCES BILE JUICE CLEARANCE. THE HEMOBILIA MAY HAVE BEEN CAUSED BY THE PRE EXISTING CONDITIONS. AS PREVIOUSLY NOTED, STENT OCCLUSION, TUMOR INGROWTH, EXCESSIVE HYPERPLASTIC TISSUE INGROWTH AND TUMOR OVERGROWTH ARE LISTED AS POTENTIAL ADVERSE EVENTS IN THE IFU/ JAPANESE PACKAGING INSERT. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS. SUMMARY: THE COMPLAINT WAS RAISED FROM LITERATURE PAPER MATSUMOTO ET AL 2022 ¿COMPARISON OF BILATERAL AND TRISEGMENT DRAINAGE IN PATIENTS WITH HIGH-GRADE HILAR MALIGNANT BILIARY OBSTRUCTION: A MULTICENTER RETROSPECTIVE STUDY¿. ACCORDING TO THE ATTACHED PAPER, 47 PATIENTS EXPERIENCED STENT OBSTRUCTION DUE TO INGROWTH, 3 PATIENTS EXPERIENCED STENT OBSTRUCTION DUE TO OVERGROWTH, 9 PATIENTS EXPERIENCED STENT OBSTRUCTION DUE TO SLUDGE AND 5 PATIENTS EXPERIENCED STENT OBSTRUCTION DUE TO HEMOBILIA. WHILE THE PATIENT OUTCOME IS NOT DETAILED IN THE PAPER, THESE INSTANCES WOULD HAVE LIKELY REQUIRED INTERVENTION OR ADDITIONAL PROCEDURES AS PER MEDICAL ADVISOR. INVESTIGATION FINDING CONCLUDE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES COULD BE ATTRIBUTED TO THE PATIENTS PRE EXISTING CONDITIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. UPDATE DEVICE NAME.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 01-JUL-2024.

    Description of Event or Problem · 0

    MATSUMOTO, 2022¿ COMPARISON OF BILATERAL AND TRISEGMENT DRAINAGE IN PATIENTS WITH HIGH-GRADE HILAR MALIGNANT BILIARY OBSTRUCTION: A MULTICENTER RETROSPECTIVE STUDY. THIS STUDY USED THE FOLLOWING SEMSS: JOSTENT SELFX UNITS (ABBOTT VASCULAR DEVICES, REDWOOD CITY, CA, USA), ZILVER STENT (COOK MEDICAL, WINSTON-SALEM, NC, USA), ZEO STENT/ZEO STENT V (ZEON MEDICAL INC., TOKYO, JAPAN), NITI-S BILIARY STENT (TAEWOONG MEDICAL CO., GIMPO, KOREA), AND BILERUSH SELECTIVE (PIOLAX, KANAGAWA, JAPAN). BILATERAL (LEFT HEPATIC DUCT AND THE ANTERIOR BRANCH OF THE RIGHT HEPATIC DUCT OR POSTERIOR BRANCH OF THE RIGHT HEPATIC DUCT) OR BILATERAL WITH TRISEGMENT (LEFT HEPATIC DUCT, ANTERIOR BRANCH OF THE RIGHT HEPATIC DUCT, AND POSTERIOR BRANCH OF THE RIGHT HEPATIC DUCT) DRAINAGE WERE PERFORMED DEPENDING ON THE PHYSICIAN¿S DISCRETION. MOST OF THE PATIENTS UNDERWENT MULTIPLE SEMS DEPLOYMENT USING THE PARTIAL STENT-IN-STENT (PSIS) METHOD. HYBRID AND SIDE-BY-SIDE METHODS WERE ALSO PERFORMED BASED ON PREVIOUS REPORTS. 47 PATIENTS WITH STENT OBSTRUCTION DUE TO INGROWTH: TUMOR INGROWTH DIAGNOSIS WAS BASED ON RADIOLOGICAL FINDINGS OF A PERSISTENT BILIARY STRICTURE INSIDE THE SEMS AFTER BILE DUCT CLEANING. 3 PATIENTS WITH STENT OBSTRUCTION DUE TO OVERGROWTH: TUMOR OVERGROWTH DIAGNOSIS WAS BASED ON THE PRESENCE OF A PERSISTENT STRICTURE OUTSIDE THE SEMS. 9 PATIENTS WITH STENT OBSTRUCTION DUE TO SLUDGE: SLUDGE WAS DIAGNOSED BASED ON THE PRESENCE OF A LARGE AMOUNT OF SLUDGE AND CLOT RESIDUE, RESPECTIVELY, IN AN OCCLUDED SEMS REVEALED DURING REINTERVENTION. 5 PATIENTS WITH STENT OBSTRUCTION DUE TO HEMOBILIA: HEMOBILIA WAS DIAGNOSED BASED ON THE PRESENCE OF A LARGE AMOUNT OF SLUDGE AND CLOT RESIDUE, RESPECTIVELY, IN AN OCCLUDED SEMS REVEALED DURING REINTERVENTION. PATIENT OUTCOME: REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4. PATIENT/EVENT INFO: BILATERAL DRAINAGE GROUP: AVERAGE AGE 76, 16 MALE/20 FEMALES. TRISEGMENT DRAINAGE GROUP: AVERAGE AGE 75, 51 MALE/38 FEMALES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278031 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention