BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 11517674 · Received March 18, 2021

    Report

    Report Number
    3001845648-2021-00208
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    August 25, 2020
    Report Date
    February 21, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 264X 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 JOURNAL ARTICLE, ¿EFFECT OF STENT PLACEMENT ON STONE RECURRENCE AND POST-PROCEDURAL CHOLANGITIS AFTER ENDOSCOPIC REMOVAL OF COMMON BILE DUCT STONES. ANOTHER COMPLAINT FILE WAS OPENED AS A RESULT OF THIS PAPER WHICH COVERS THE UNKNOWN ZIMMON BILIARY STENT OFF-LABEL USAGE DUE TO THE RISE IN THE INITIAL ASPARTATE AMINOTRANSFERASE (AST) AND ALANINE AMINOTRANSFERASE (ALT) LEVELS. LAB EVALUATION ¿ N/A. IMAGE REVIEW ¿ N/A . DOCUMENT REVIEW: 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 (IFU0045-7) ¿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 IN AN ALTERED ANATOMY IS BEING DISCUSSED. IT IS CONFIRMED FROM THE JOURNAL THAT A PAPILLARY BALLOON DILATER WAS USED TO ASSIST THE STENT PLACEMENT FOR PATIENTS WITH AN ALTERED ANATOMY (PERIAMPULLARY DIVERTICULUM OR BILLROTH II GASTROJEJUNOSTOMY). PLACEMENT OF ZIMMON BILIARY STENT PIGTAIL IN AN ALTERED PATIENT ANATOMY IS CONSIDERED OFF-LABEL USE. 20 PATIENTS AMONG THE STENTING GROUP EXPERIENCED STONE RECURRENCE WHICH WAS LIKELY DUE TO PATIENT¿S HEALTH CONDITION. 7 PATIENTS EXPERIENCED POST PROCEDURAL CHOLANGITIS, 4 EXPERIENCED BLEEDING AND 18 PATIENTS HAD POST-ERCP PANCREATITIS. HOWEVER, THE MEDICAL ADVISOR HAS CONFIRMED THAT THESE COMPLICATIONS ARE LIKELY DUE TO THE ERCP PROCEDURE AN CANNOT BE ATTRIBUTED AS AN ¿ADVERSE EVENT¿ RELATED TO STENT. AS PER THE JOURNAL, THERE WAS NO BILIARY STENT-RELATED ADVERSE EVENT IN THE STENTING GROUP AND ALL OTHER COMPLICATIONS WERE IMPROVED BY CONSERVATIVE THERAPY OR ENDOSCOPIC PROCEDURES. ROOT CAUSE REVIEW: 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. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ALL COMPLICATIONS WERE IMPROVED BY CONSERVATIVE THERAPY OR ENDOSCOPIC PROCEDURES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT BEING SUBMITTED AS DESCRIPTION OF EVENT HAS BEEN UPDATED TO CAPTURE OFF LABEL USE FOR BOTH USE IN ALTERED PATIENT ANATOMY AND PROPHYLACTIC USE. SEE BELOW. CHOI 2020, DOUBLE PIG TAIL STENT ¿ EFFECT OF STENT PLACEMENT ON STONE RECURRENCE AND POST-PROCEDURAL CHOLANGITIS AFTER ENDOSCOPIC REMOVAL OF COMMON BILE DUCT STONES. AFTER ENDOSCOPIC TREATMENT OF COMMON BILE DUCT (CBD) STONES, RECURRENCE OF CHOLEDOCHOLITHIASIS DUE TO SMALL STONE FRAGMENTS AND POST-ENDO¬SCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (POST-ERCP) CHOLANGITIS CAN OCCUR. WE DETERMINED THE EFFECT OF BILIARY STENTING AFTER REMOVAL OF CBD STONES ON THE RECURRENCE OF CBD STONES AND THE INCIDENCE OF POST-ERCP CHOLANGITIS. ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY WAS PERFORMED USING A SIDE-VIEW ENDOSCOPE (JF-260, TJF-240, OR TJF 260, OLYMPUS OPTICAL CO., TOKYO, JAPAN). AFTER A DIAGNOSTIC CHOLANGIOGRAM AND WIRE-GUIDED CANNULATION, EST WAS CONDUCTED USING A PULL-TYPE SPHINCTEROTOME. FOR PATIENTS WITH AN ALTERED ANATOMY (PERIAMPULLARY DIVERTICULUM OR BILLROTH II GASTROJEJUNOSTOMY) AND FOR THE REMOVAL OF LARGE STONES (> 10 MM DIAMETER) OR = 5 BILE DUCT STONES, A PAPILLARY BALLOON DILATER (CRE BALLOON, BOSTON SCIENTIFIC MICROINVASIVE, CORK, IRELAND) WAS PASSED OVER THE GUIDEWIRE AND POSITIONED AT THE MIDDLE OF THE BALLOON ACROSS THE ORIFICE OF THE AMPULLA. FOR PATIENTS WITH SEVERE CHOLANGITIS, = 3 STONES, PERIAMPULLARY DIVERTICULUM, OR PAPILLARY EDEMA ON THE CHOLANGIOGRAM AFTER STONE REMOVAL AND LACK OF CONTRAST MEDIUM DRAINAGE TO THE DUODENUM, THE PROCEDURE WAS COMPLETED AFTER THE INSERTION OF A 7-FR PLASTIC BILIARY STENT (DOUBLE PIGTAIL BILIARY STENT, WILSON COOK MEDICAL INC., BLOOMINGTON, IN, USA). OFF LABEL USE: USE IN ALTERED PATIENT ANATOMY AND PROPHYLACTIC USE. NO ADVERSE EFFECTS REPORTED.

    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 ON THE 21-FEB-2022.

    Description of Event or Problem · 0

    CHOI 2020, DOUBLE PIG TAIL STENT ¿ EFFECT OF STENT PLACEMENT ON STONE RECURRENCE AND POST-PROCEDURAL CHOLANGITIS AFTER ENDOSCOPIC REMOVAL OF COMMON BILE DUCT STONES. AFTER ENDOSCOPIC TREATMENT OF COMMON BILE DUCT (CBD) STONES, RECURRENCE OF CHOLEDOCHOLITHIASIS DUE TO SMALL STONE FRAGMENTS AND POST-ENDO¬SCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (POST-ERCP) CHOLANGITIS CAN OCCUR. WE DETERMINED THE EFFECT OF BILIARY STENTING AFTER REMOVAL OF CBD STONES ON THE RECURRENCE OF CBD STONES AND THE INCIDENCE OF POST-ERCP CHOLANGITIS. ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY WAS PERFORMED USING A SIDE-VIEW ENDOSCOPE (JF-260, TJF-240, OR TJF 260, OLYMPUS OPTICAL CO., TOKYO, JAPAN). AFTER A DIAGNOSTIC CHOLANGIOGRAM AND WIRE-GUIDED CANNULATION, EST WAS CONDUCTED USING A PULL-TYPE SPHINCTEROTOME. FOR PATIENTS WITH AN ALTERED ANATOMY (PERIAMPULLARY DIVERTICULUM OR BILLROTH II GASTROJEJUNOSTOMY) AND FOR THE REMOVAL OF LARGE STONES (> 10 MM DIAMETER) OR = 5 BILE DUCT STONES, A PAPILLARY BALLOON DILATER (CRE BALLOON, BOSTON SCIENTIFIC MICROINVASIVE, CORK, IRELAND) WAS PASSED OVER THE GUIDEWIRE AND POSITIONED AT THE MIDDLE OF THE BALLOON ACROSS THE ORIFICE OF THE AMPULLA. FOR PATIENTS WITH SEVERE CHOLANGITIS, = 3 STONES, PERIAMPULLARY DIVERTICULUM, OR PAPILLARY EDEMA ON THE CHOLANGIOGRAM AFTER STONE REMOVAL AND LACK OF CONTRAST MEDIUM DRAINAGE TO THE DUODENUM, THE PROCEDURE WAS COMPLETED AFTER THE INSERTION OF A 7-FR PLASTIC BILIARY STENT (DOUBLE PIGTAIL BILIARY STENT, WILSON COOK MEDICAL INC., BLOOMINGTON, IN, USA). OFF LABEL USE: USE IN ALTERED PATIENT ANATOMY. NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415688 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male