BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON PANCREATIC STENT

    MDR report key: 10689256 · Received October 16, 2020

    Report

    Report Number
    3001845648-2020-00795
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    October 28, 2015
    Report Date
    May 21, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT INFORMATION NOT PROVIDED POSSIBLE 510 K CODE'S: K900923 & K990130. DEVICE EVALUATION: THE ZIMMON PANCREATIC STENT, 5FR-5CM, OF UNKNOWN LOT NUMBER AND RPN 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, "WIRE-GUIDED CANNULATION OVER A PANCREATIC STENT VERSUS DOUBLE GUIDEWIRE TECHNIQUE IN PATIENTS WITH DIFFICULT BILIARY CANNULATION" . COMPLAINT FILE PR310207 WAS OPENED AS A RESULT OF THIS PAPER. THIS FILE COVERS 139 CASES FOR OFF LABEL PROPHYLACTIC USE OF THE ZIMMON PANCREATIC STENT, 5FR-5CM, THAT WAS USED. (RPN: UNKNOWN). DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZIMMON PANCREATIC 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 (IFU0055-4) "THIS DEVICE IS USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ WHERE THE PROPHYLACTIC USE OF THE DEVICE IN THIS PROCEDURE IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEEN TESTED IN A CLINICAL SETTING. THE AIM OF THIS STUDY WAS TO COMPARE THE OUTCOMES OF WGC-PS (WIRE-GUIDED CANNULATION OVER A PANCREATIC STENT) AND DGT (DOUBLE GUIDEWIRE TECHNIQUE) IN PATIENTS WITH DIFFICULT BILIARY CANNULATION BETWEEN JULY 2009 AND NOVEMBER 2014. ERCP (ENDOSCOPIC RETROGRADE PANCREATOGRAPHY) WAS PERFORMED AND SELECTIVE BILIARY CANNULATION WAS FIRST ATTEMPTED BY THE STANDARD WGC TECHNIQUE WITH A 0.035" GUIDEWIRE (TRACER METRO® DIRECT ¿ WIRE GUIDE; WILSON-COOK MEDICAL INC., WINSTON-SALEM, NC, USA OR FUSION® LOOPTIP¿ WIRE GUIDE; WILSON-COOK ¿ MEDICAL INC., WINSTON-SALEM, NC, USA). FOR WGC-PS, A POLYTHENE STENT (5FR, 5CM, ZIMMON STENT, COOK IRELAND LTD., LIMERICK, IRELAND) WAS PLACED INTO THE MAIN PD. WGC-PS WAS PERFORMED AS FOLLOWS. CANNULATION OF THE BILE DUCT THEN WAS ATTEMPTED USING A SPHINCTEROTOME, WHICH WAS PRELOADED WITH A GUIDEWIRE. THE SPHINCTEROTOME WAS DIRECTED TO THE BILIARY ORIFICE AT ITS USUAL 10¿11 O'CLOCK POSITION ON THE AMPULLA USING THE PD STENT AS A REFERENCE POINT. WGC OF THE BILE WAS ATTEMPTED OVER THE PD STENT. THIS FILE IS BEING CREATED TO CAPTURE 139 STENTS PLACED, THE 90 PATIENTS IN THE WGC-PS GROUP AND 49 (56.3% OF 87) IN THE DGT GROUP WHO ZIMMON PANCREATIC STENT PLACED PROPHYLACTICALLY TO PREVENT POST ERCP PANCREATITIS WHICH IS CONSIDERED OFF LABEL USE PEP (POST- ERCP PANCREATITIS) DEVELOPED IN 3.3 % (THREE PATIENTS, MILD) OF PATIENTS IN THE WGC-PS GROUP AND 10.3 % (SEVEN PATIENTS, MILD AND TWO PATIENTS, MODERATE) OF PATIENTS IN THE DGT GROUP. NO BLEEDING OR PERFORATION OCCURRED IN EITHER GROUP. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE IT STATED INTENDED USE IN THIS CASE PROPHYLACTIC USE OF THE DEVICE IT CAN RESULT IN OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. IN THIS STUDY THERE WAS 139 STENTS PLACED, 90 PATIENTS IN THE WGC-PS GROUP AND 49 (56.3% OF 87) IN THE DGT GROUP HAD ZIMMON PANCREATIC STENTS PLACED PROPHYLACTICALLY TO PREVENT POST ERCP PANCREATITIS WHICH IS CONSIDERED OFF LABEL USE ACCORDING TO OUR CLINICAL ADVISER, THE PANCREATITIS THAT OCCURRED IN THREE PATIENTS IN THE WGC-PS GROUP AND SEVEN PATIENTS IN THE DGT GROUP WAS NOT RELATED TO THE COOK STENT. SUMMARY: COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED THERE WAS NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE OFF-LABEL USE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FINAL MDR BEING SUBMITTED FOR THE COMPLETION OF INVESTIGATION ON 21-MAY-21. RESULTS AND CONCLUSIONS ARE OUTLINED IN SECTION H OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT INFORMATION NOT PROVIDED POSSIBLE 510 K CODE'S: K900923 & K990130. INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    YANG ET AL 2015 ¿WIRE-GUIDED CANNULATION OVER A PANCREATIC STENT VERSUS DOUBLE GUIDEWIRE TECHNIQUE IN PATIENTS WITH DIFFICULT BILIARY CANNULATION¿. IN CASES OF DIFFICULT BILE DUCT CANNULATION, THE USE OF WIRE-GUIDED CANNULATION OVER A PANCREATIC STENT (WGC-PS) OR THE DOUBLE GUIDEWIRE TECHNIQUE (DGT) MAY FACILITATE BILIARY CANNULATION. THE AIM OF THIS STUDY WAS TO COMPARE THE OUTCOMES OF WGC-PS AND DGT IN PATIENTS WITH DIFFICULT BILIARY CANNULATION. WE CONDUCTED A RETROSPECTIVE COHORT STUDY OF ALL ERCPS PERFORMED BETWEEN JULY 2009 AND NOVEMBER 2014 AT A SINGLE TERTIARY REFERRAL HOSPITAL (AJOU UNIVERSITY HOSPITAL, SUWON, KOREA). DURING THE STUDY PERIOD, WGC-PS OR DGT WAS PERFORMED IN PATIENTS FOR WHOM BILIARY CANNULATION WAS DIFFICULT AND GUIDEWIRE INSERTION INTO THE PD WAS ACHIEVED BY UNINTENTIONAL PD CANNULATION WHILE ATTEMPTING THE STANDARD WGC TECHNIQUE. WGC-PS WAS PERFORMED AS FOLLOWS. AFTER A GUIDEWIRE WAS PLACED INTO THE PD, A POLYETHYLENE STENT (5 F AND 5- CM, ZIMMON STENT, COOK IRELAND LTD., LIMERICK, IRELAND) WAS PLACED INTO THE MAIN PD. CANNULATION OF THE BILE DUCT THEN WAS ATTEMPTED USING A SPHINCTEROTOME, WHICH WAS PRELOADED WITH A GUIDEWIRE. THE SPHINCTEROTOME WAS DIRECTED TO THE BILIARY ORIFICE AT ITS USUAL 10¿11 O¿CLOCK POSITION ON THE AMPULLA USING THE PD STENT AS A REFERENCE POINT. WGC OF THE BILE DUCT WAS ATTEMPTED OVER THE PD STENT A TOTAL OF 177 PATIENTS WHO UNDERWENT DGT AND/OR WGC-PS WERE ENROLLED IN THIS STUDY, 90 PATIENTS IN THE WGC-PS GROUP AND 87 PATIENTS IN THE DGT GROUP. THE ONLY SIGNIFICANT DIFFERENCE WAS A HIGHER PERCENTAGE OF PD STENT PLACEMENT IN THE WGCPS GROUP COMPARED WITH THE DGT GROUP (100 % VS. 56.3 %, P < 0.001). PEP DEVELOPED IN 3.3 % (THREE PATIENTS, MILD) OF PATIENTS IN THE WGC-PS GROUP. THE RATE OF PEP WAS SIGNIFICANTLY HIGHER IN THE PATIENTS WITHOUT PANCREATIC STENTING IN THE DGT GROUP THAN THE PATIENTS IN THE WGC-PS GROUP. NO BLEEDING OR PERFORATION OCCURRED IN EITHER GROUP. THIS FILE IS BEING CREATED TO CAPTURE 139 STENTS PLACED, THE 90 PATIENTS IN THE WGC-PS GROUP AND 49 (56.3% OF 87) IN THE DGT GROUP WHO ZIMMON PANCREATIC STENT PLACED PROPHYLACTICALLY TO PREVENT POST ERCP PANCREATITIS WHICH IS CONSIDERED OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157526 ZIMMON PANCREATIC STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR