BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON PANCREATIC STENT

    MDR report key: 10620814 · Received October 2, 2020

    Report

    Report Number
    3001845648-2020-00736
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Report Date
    February 19, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANNEX G: G07001 - PART/COMPONENT/ SUB-ASSEMBLY TERM NOT APPLICABLE. DEVICE EVALUATION: THE ZIMMON PANCREATIC STENT 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. IT IS KNOWN THAT THE CIRL STENTS USED WERE ZIMMON PANCREATIC STENTS, POSSIBILITIES COULD INCLUDE SPSOF OR ZPSOF FROM THE DESCRIPTION IN THE PAPER, HOWEVER AS RPN CANNOT BE CONFIRMED IT IS DOCUMENTED AS UNKNOWN. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. ¿NEEDLE KNIFE SPHINCTEROTOMY DOES NOT INCREASE THE RISK OF PANCREATITIS IN PATIENTS WITH DIFFICULT BILIARY CANNULATION." 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 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. THE INSTRUCTIONS FOR USE, IFU0055-4 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ 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 USE OF THE DEVICE IN THIS PROCEDURE IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEING TESTED IN A CLINICAL SETTING. AS PER INFORMATION STATED IN THE PAPER ENDOSCOPISTS PLACED A PANCREATIC STENT BEFORE NEEDLE KNIFE SPHINCTEROTOMY (NKS) IF THE PANCREATIC DUCT HAD BEEN CANNULATED AT LEAST TWICE, IF IT HAD NOT BEEN CANNULATED THEN A STENT WAS NOT PLACED. IT WAS ALSO NOTED THAT CANNULATION WAS PERFORMED WITH THE NKS TECHNIQUE. PANCREATIC STENTS WERE INSERTED IN 43 PATIENTS, 5 IN THE EARLY SUCCESS (ES) GROUP AND 38 IN THE RANDOMISED GROUP (15 WITH CONTINUED STANDARD THERAPY (CS) AND 23 WITH NKS). AS PER CLINICAL INPUT THE REASON FOR THE STENT PLACEMENT WAS OFF LABEL AS THEY WERE USED TO PREVENT POST ERCP PANCREATITIS AND TO FACILITATE BILIARY CANNULATION. BOTH THE PANCREATITIS EXPERIENCED BY THE PATIENTS WITH STENTS INSERTED AND THE POST-SPHINCTEROTOMY BLEEDING WAS CONFIRMED BY CLINICAL ADVISEMENT AS NOT DEVICE RELATED ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, IF A PANCREATIC STENT WAS INSERTED THEN PATIENTS RETURNED FOR AN ABDOMINAL X-RAY ON DAY 7, IF THE STENT WAS STILL PRESENT THEN IT WAS RETRIEVED ENDOSCOPICALLY WITHIN THE FOLLOWING 24 HOURS. THERE WERE NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE USE OF THE ZIMMON PANCREATIC STENT DEVICE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON THE 19-FEB-2021. SWAN 2013 ¿ NEEDLE KNIFE SPHINCTEROTOMY DOES NOT INCREASE THE RISK OF PANCREATITIS IN PATIENTS WITH DIFFICULT BILIARY CANNULATION. PROCEDURES WERE PERFORMED IN A DEDICATED ENDOSCOPIC FLUOROSCOPY ROOM, WITH THE PATIENT IN THE PRONE POSITION WITH MONITORED ANESTHESIA CARE BY USING PROPOFOL-BASED SEDATION. AN OLYMPUS EXERA TJF-160R DUODENOSCOPE (OLYMPUS OPTICAL, (B)(6) , TOKYO) WAS USED IN ALL CASES. ALL PROCEDURES WERE COMMENCED WITH A WIRE-GUIDED CANNULATION TECHNIQUE THAT HAS BEEN PREVIOUSLY DESCRIBED IN DETAIL, 4 WHICH USES A TRIPLE-LUMEN SPHINCTEROTOME (CLEVERCUT3; OLYMPUS OPTICAL CO, LTD) AND A 400-MM LENGTH HYDROPHILIC WIRE (JAGWIRE; BOSTON SCIENTIFIC, NATICK, MA). IF REQUIRED, AN NKS WAS PERFORMED BY USING A 3-MM-LONG OLYMPUS NEEDLE KNIFE (OLYMPUS OPTICAL CO). PANCREATIC STENTS WERE INSERTED IN 43 PATIENTS (9.3%), 5 IN THE ES GROUP (1.3%) AND 38 IN THE RANDOMIZED GROUP (52%) (P.01). FILE BEING OPENED TO CAPTURE ¿OFF LABEL USE: TO FACILITATE BILIARY CANNULATION.¿

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SWAN 2013: NEEDLE KNIFE SPHINCTEROTOMY DOES NOT INCREASE THE RISK OF PANCREATITIS IN PATIENTS WITH DIFFICULT BILIARY CANNULATION. PROCEDURES WERE PERFORMED IN A DEDICATED ENDOSCOPIC FLUOROSCOPY ROOM, WITH THE PATIENT IN THE PRONE POSITION WITH MONITORED ANESTHESIA CARE BY USING PROPOFOL-BASED SEDATION. AN OLYMPUS EXERA TJF-160R DUODENOSCOPE (OLYMPUS OPTICAL, JAPAN, TOKYO) WAS USED IN ALL CASES. ALL PROCEDURES WERE COMMENCED WITH A WIRE-GUIDED CANNULATION TECHNIQUE THAT HAS BEEN PREVIOUSLY DESCRIBED IN DETAIL, 4, WHICH USES A TRIPLE-LUMEN SPHINCTEROTOME (CLEVER CUT; OLYMPUS OPTICAL CO, LTD) AND A 400-MM LENGTH HYDROPHILIC WIRE (JAGWIRE; BOSTON SCIENTIFIC, NATICK, MA). IF REQUIRED, AN NKS WAS PERFORMED BY USING A 3-MM-LONG OLYMPUS NEEDLE KNIFE (OLYMPUS OPTICAL CO). PANCREATIC STENTS WERE INSERTED IN 43 PATIENTS (9.3%), 5 IN THE ES GROUP (1.3%) AND 38 IN THE RANDOMIZED GROUP (52%) (P.01) FILE BEING OPENED TO CAPTURE ¿OFF LABEL USE: TO FACILITATE BILIARY CANNULATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086848 ZIMMON PANCREATIC STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR