BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 11525348 · Received March 19, 2021

    Report

    Report Number
    3001845648-2021-00216
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    August 29, 2019
    Report Date
    April 29, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1 X ZIMMON BILIARY STENT DEVICE OF UNKNOWN RPN AND OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, ¿ENDOSCOPIC TRANSPAPILLARY GALLBLADDER STENTING USING A NEWLY DESIGNED PLASTIC STENT FOR ACUTE CHOLECYSTITIS¿ THIS COMPLAINT FILE WAS OPENED AS A RESULT OF THIS PAPER WHICH COVERS THE UNKNOWN ZIMMON BILIARY STENT OFF-LABEL USAGE DUE TO THE DEVICE BEING PLACED INTO THE GALLBLADDER. AS THE RPN AND LOT NUMBER OF THE PLASTIC STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZIMMON BILIARY STENT 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 DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE ¿TO DRAIN OBSTRUCTED BILIARY DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ IN THIS JOURNAL, AN OFF-LABEL USAGE OF A ZIMMON BILIARY STENT DEVICE BEING PLACED UNDER ENDOSCOPIC TRANSPAPILLARY GALLBLADDER DRAINAGE (ETGBD) IS DISCUSSED. PLACEMENT OF ZIMMON BILIARY STENT PIGTAIL IN THE GALLBLADDER IS CONSIDERED OFF-LABEL USE. 2 PATIENTS AMONG THE CONTROL GROUP EXPERIENCED PANCREATITIS OF WHICH ONE HAD BEEN REPORTED TO HAVE A PIGTAIL STENT PLACED. EST BLEEDING IN ONE PATIENT, OBSTRUCTIVE JAUNDICE IN THREE, CYSTIC DUCT PERFORATION IN ONE AND A STENT KINK IN ONE HAS ALSO BEEN REPORTED. THE BILIARY STENT IS TO TREAT OBSTRUCTED BILE DUCT AND TO IMPROVE EXISTING JAUNDICE, THE BILIARY STENT IS NOT TO OBSTRUCT THE BILE DUCT. THE JAUNDICE IN THIS ARTICLE WAS DUE TO STENT PLACEMENT WITHOUT EST; HOWEVER, EST IS NOT A STANDARD PROCEDURE IN REGARD TO STENT PLACEMENT, UNLESS THE STENT ITSELF WAS OCCLUDED. THE CLINICAL ADVISOR HAS CONFIRMED THAT THE CYSTIC DUCT PERFORATION AND SUBSEQUENT AE IS DUE TO THE OFF LABEL PLACEMENT PROCEDURE. AN USER ERROR WITH RESPECT TO THE MODIFICATION OF THE STENT BY CUTTING VARIOUS TYPES OF NASOBILIARY TUBES ALSO HAS BEEN REPORTED IN THE JOURNAL. IT MAY BE NOTED THE DEVICE IFU MENTIONS ¿THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. ATTEMPTS TO REPROCESS, RESTERILIZE, AND/OR REUSE MAY LEAD TO DEVICE FAILURE AND/OR TRANSMISSION OF DISEASE. THERE IS EVIDENCE FROM THE JOURNAL TO STATE THAT THE USER DIDN¿T FOLLOW THE INSTRUCTIONS FOR USE. AS PER THE JOURNAL, ALL EARLY AES WERE IMPROVED BY CONSERVATIVE THERAPY OR ENDOSCOPIC PROCEDURES. A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED USE IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ALL EARLY AES WERE IMPROVED BY CONSERVATIVE THERAPY OR ENDOSCOPIC PROCEDURES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    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.

    Additional Manufacturer Narrative · 1

    ANNEX G: G04122 - STENT. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    NAKAWARA 2019 (ZIMMON BS)  ENDOSCOPIC TRANSPAPILLARY GALLBLADDER STENTING USING A NEWLY DESIGNED PLASTIC STENT FOR ACUTE CHOLECYSTITIS. OBJECTIVE: SEVENTY PATIENTS WITH ACUTE CHOLECYSTITIS IN WHOM EGBS WAS PERFORMED WERE EVALUATED RETROSPECTIVELY. WE PERFORMED EGBS IN 23 PATIENTS USING THE NOVEL STENT (NOVEL STENT GROUP) AND 47 PATIENTS USING STANDARD BILIARY STENTS (PIGTAIL: 35, STRAIGHT: 12) (CONTROL GROUP). IN THE TWO GROUPS, WE EXAMINED OUTCOMES OF EGBS. PROCEDURE: (OFF-LABEL USE: PLACING ONE PIGTAIL INTO THE GALLBLADDER) WE USED A DUODENOSCOPE (JF260V OR TJF260V; OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) AND PERFORMED BILE DUCT CANNULATION BY CONVENTIONAL CONTRAST CANNULATION OR WIRE-GUIDED CANNULATION. AFTER BILE DUCT CANNULATION, A HYDROPHILIC GW (E. G., RADIFOCUS, TERUMOCO., LTD.,TOKYO,JAPAN)WAS PASSED THROUGH THE CYSTIC DUCT AND INSERTED INTO THE GALLBLADDER. AFTER CHANGING THE GW TO A STIFF TYPE, WE INSERTED A 7-FR TAPERED CATHETER WITH SIDE HOLES (CX-PTCD KIT [PD-EN7F (ST) 180C4], GADELIUS MEDICAL, TOKYO, JAPAN) INTO THE GALLBLADDER OVER THE GW, SUCTIONED THE BILE, AND SUBSEQUENTLY IRRIGATED THE GALLBLADDER WITH SALINE. NEXT, WE MEASURED THE LENGTH FROM THE PAPILLA TO THE GALLBLADDER USING THE GW AND PLACED THE STENT SO THAT THE TIP WAS AT THE FUNDUS OF THE GALLBLADDER. THE STENTS USED IN THE CONTROL GROUP WERE 1 ZIMMON BILIARY STENT (COOK JAPAN, TOKYO, JAPAN). MILD PANCREATITIS: ALL EARLY AES WERE IMPROVED BY CONSERVATIVE THERAPY OR ENDOSCOPIC PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428031 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention