BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 9929131 · Received April 6, 2020

    Report

    Report Number
    3001845648-2020-00203
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    July 17, 2019
    Report Date
    August 30, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K182980. THIS REPORT IS BEING SUBMITTED TO UPDATE THE FILE WITH DATA RECEIVED ON 09-JUL-2020 FROM AN ADDITIONAL LITERATURE ARTICLE INVOLVING THE SAME PATIENTS. 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 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 ZIB6 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 PROVIDED IT IS KNOWN THAT THE STENTS WERE PLACED IN PATIENTS WITH AN INFRAHILAR BILIARY OBSTRUCTION. THE TUMORS HAD TO BE UNRESECTABLE, CAUSING AN OBSTRUCTION NOT AMENABLE TO ENDOSCOPY, AND COULD BE PRIMARY OR SECONDARY METASTATIC. IT IS POSSIBLE THAT THE PATIENT¿S CONDITION PROGRESSED RESULTING IN TUMOR GROWTH RESULTING IN THE STENT BECOMING OCCLUDED. AS PREVIOUSLY MENTIONED, THE STET IS NOT DESIGNED TO INHIBIT TUMOR INGROWTH. HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CHARACTERISTICS DETERIORATED OR THE DEVICE MALFUNCTIONED DURING THE STUDY. THEREFORE, PATIENT PRE-EXISTING CONDITIONS MORE LIKELY CONTRIBUTED TO THE EVENTS OF STENT OCCLUSION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ADDITIONAL LITERATURE PAPER RECEIVED 09-JUL-2020. DHONDT ET AL 2019 ¿NO EVIDENCE OF IMPROVED EFFICACY OF COVERED STENTS OVER UNCOVERED STENTS IN PERCUTANEOUS PALLIATION OF MALIGNANT HILAR BILIARY OBSTRUCTION: RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL.¿ PROCEDURE: PATIENTS WITH OBSTRUCTIVE JAUNDICE CAUSED BY AN UNRESECTABLE HILAR MALIGNANCY WERE INCLUDED AFTER FAILED ENDOSCOPIC INTERVENTION IN A PROSPECTIVE RANDOMIZED TRIAL COMPARING EXPANDED POLYTETRAFLUOROETHYLENE AND FLUORINATED ETHYLENE PROPYLENE (EPTFE-FEP)¿COVERED NITINOL STENTS WITH UNCOVERED NITINOL STENTS AS THE CONTROL STENT, THE ZA BILIARY STENT (COOK) WAS USED. THIS IS A SELF-EXPANDING HANDWOVEN NITINOL SEMS WITH A Z-CONFIGURATION. THE STENTS HAD A DIAMETER OF 10 MM WITH A LENGTH OF 6 OR 8 CM. AFTER A FABRICATION STOP IN 2008, THE STUDY WAS CONTINUED WITH THE NITINOL LASER-CUT ZILVER SEM (COOK) WITH THE SAME DIMENSIONS. THE OCCLUSION LEVEL WAS DEFINED AS HILAR WHEN THE CONFLUENCE OF THE RIGHT AND LEFT HEPATIC DUCTS WAS INVOLVED OR WHEN THE OBSTRUCTION WAS LOCATED LESS THAN 15 MM BELOW THE HILUM. OCCLUSION RATE FOR UNCOVERED STENT WAS 31/54 (57%). BEFORE DEATH 15/54 (28%), AT END OF LIFE 18/50 (36%). THE PRESENTED OCCLUSION RATES OF 57% WITH UNCOVERED STENTS SEEM HIGH; HOWEVER, BY DEFINITION, RATES ALSO COMPRISE PATIENTS WHO DIED IN JAUNDICE. IT CAN BE NOTED THAT STENT OCCLUSION RATES INCLUDED IN THIS PAPER MAY HAVE ALREADY BEEN INCLUDED IN THE PREVIOUS REPORTS SUBMITTED AND IT IS ASSUMED THAT SOME OF THE PATIENTS FROM BOTH ARTICLES HAVE OVERLAPPED.

    Description of Event or Problem · 0

    THIS IS A COMPLETE REPORT. THE INVESTIGATION WAS COMPLETED ON 30-AUG-2020. RESULTS AND CONCLUSIONS ARE OUTLINED IN SECTION H OF THIS REPORT DHONDT ET AL 2019 ¿NO EVIDENCE OF IMPROVED EFFICACY OF COVERED STENTS OVER UNCOVERED STENTS IN PERCUTANEOUS PALLIATION OF MALIGNANT HILAR BILIARY OBSTRUCTION: RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL¿. PROCEDURE: PATIENTS WITH OBSTRUCTIVE JAUNDICE CAUSED BY AN UNRESECTABLE HILAR MALIGNANCY WERE INCLUDED AFTER FAILED ENDOSCOPIC INTERVENTION IN A PROSPECTIVE RANDOMIZED TRIAL COMPARING EXPANDED POLYTETRAFLUOROETHYLENE AND FLUORINATED ETHYLENE PROPYLENE (EPTFE-FEP)¿COVERED NITINOL STENTS WITH UNCOVERED NITINOL STENTS AS THE CONTROL STENT, THE ZA BILIARY STENT (COOK) WAS USED. THIS IS A SELF-EXPANDING HANDWOVEN NITINOL SEMS WITH A Z-CONFIGURATION. THE STENTS HAD A DIAMETER OF 10 MM WITH A LENGTH OF 6 OR 8 CM. AFTER A FABRICATION STOP IN 2008, THE STUDY WAS CONTINUED WITH THE NITINOL LASER-CUT ZILVER SEM (COOK) WITH THE SAME DIMENSIONS. THE OCCLUSION LEVEL WAS DEFINED AS HILAR WHEN THE CONFLUENCE OF THE RIGHT AND LEFT HEPATIC DUCTS WAS INVOLVED OR WHEN THE OBSTRUCTION WAS LOCATED LESS THAN 15 MM BELOW THE HILUM. OCCLUSION RATE FOR UNCOVERED STENT WAS 31/54 (57%). BEFORE DEATH 15/54 (28%); AT END OF LIFE 18/50 (36%). THE PRESENTED OCCLUSION RATES OF 57% WITH UNCOVERED STENTS SEEM HIGH; HOWEVER, BY DEFINITION, RATES ALSO COMPRISE PATIENTS WHO DIED IN JAUNDICE. IT CAN BE NOTED THAT STENT OCCLUSION RATES INCLUDED IN THIS PAPER MAY HAVE ALREADY BEEN INCLUDED IN THE PREVIOUS REPORTS SUBMITTED AND IT IS ASSUMED THAT SOME OF THE PATIENTS FROM BOTH ARTICLES HAVE OVERLAPPED.

    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

    DHONDT - ¿NO ADVANTAGE OF EXPANDED POLYTETRAFLUOROETHYLENE AND FLUORINATED ETHYLENE PROPYLENE¿COVERED STENTS OVER UNCOVERED NITINOL STENTS FOR PERCUTANEOUS PALLIATION OF MALIGNANT INFRAHILAR BILIARY OBSTRUCTION: RESULTS OF A SINGLE-CENTER PROSPECTIVE RANDOMIZED TRIAL.¿ PROCEDURE: THE INITIAL CHOICE OF UNCOVERED STENT WAS THE ZA BILIARY STENT (COOK EUROPE, LIMERICK, IRELAND), WHICH IS A HANDWOVEN NITINOL SEMS WITH A Z-CONFIGURATION. THE 10-MM DIAMETER VERSION HAS A LENGTH OF 6 OR 8 CM. AFTER FABRICATION OF THIS DEVICE WAS STOPPED IN MARCH 2008, THE STUDY CONTINUED WITH ITS SUCCESSOR, THE LASER-CUT NITINOL ZILVER SEMS, WITH THE SAME DIMENSIONS. THE STENOSIS WAS DILATED WITH AN 8¿10-MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON (SYNERGY [BOSTON SCIENTIFIC] OR MARS [OPTIMED, ETTLINGEN, GERMANY]). STENTS WERE ROUTINELY PLACED DURING THE SAME PROCEDURE ACROSS THE PAPILLA OF VATER. IN CASES IN WHICH THE TUMOR WAS LOCATED AT A DISTANCE FROM THE PAPILLA, SUPRAPAPILLARY STENT PLACEMENT WAS AN OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393352 ZILVER BILIARY SELF-EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention