BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER BILIARY SELF-EXPANDING METAL STENT

    MDR report key: 9930572 · Received April 6, 2020

    Report

    Report Number
    3001845648-2020-00206
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    July 17, 2019
    Report Date
    January 7, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0040-6). A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IT IS KNOWN THAT THE PATIENTS IN THIS STUDY HAD OBSTRUCTIVE JAUNDICE CAUSED BY AN UNRESPECTABLE HILAR MALIGNANCY. IT IS POSSIBLE THAT THE PATIENTS PRE-EXISTING CONDITION CONTRIBUTED TO THE MAJOR ADVERSE EVENTS AND WERE PROCEDURE RELATED. THE MAJOR ADVERSE EVENTS WERE CARDIAC [2], PULMONARY [2], BLEEDING REQUIRING REINTERVENTION [4], SEPSIS [1], AND SEPTIC SHOCK [2]. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS REQUIRED A SECONDARY INTERVENTION. 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. MAJOR COMPLICATIONS: THORACIC DRAINAGE (2) AS PER TABLE 3. THERE WERE 12 MAJOR COMPLICATIONS IN THE UNCOVERED STENT GROUP. IT CAN BE NOTED THAT OTHER MAJOR COMPLICATION INCLUDED IN THIS PAPER HAVE ALREADY BEEN INCLUDED ABOVE AND IT IS ASSUMED THAT SOME OF THE PATIENTS FROM BOTH ARTICLES HAVE OVERLAPPED. 12 MAJOR AES PULMONARY [2], BLEEDING REQUIRING REINTERVENTION [4], SEPSIS [3] AND SEPTIC SHOCK [1].

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    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-MMDIAMETER 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. 11 MAJOR AES (CARDIAC [2], PULMONARY [2], BLEEDING REQUIRING REINTERVENTION [4], SEPSIS [1], AND SEPTIC SHOCK [2]).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392285 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 Unknown Life Threatening| H| R