BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 19972257 · Received August 13, 2024

    Report

    Report Number
    3001845648-2024-00459
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    April 1, 2018
    Report Date
    July 29, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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

    CANCELLATION REPORT BEING SUBMITTED AS THIS EVENT NO LONGER MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    JAGIELSKI ET AL 2018 ¿ THE DEVELOPMENT OF ENDOSCOPIC TECHNIQUES FOR TREATMENT OF WALLED-OFF PANCREATIC NECROSIS: A SINGLE-CENTER EXPERIENCE. THE STUDY GROUP COMPRISED 101 PATIENTS WITH SYMPTOMATIC WALLED-OFF PANCREATIC NECROSIS WHO UNDERWENT ENDOSCOPIC THERAPY IN OUR DEPARTMENT OVER A 5-YEAR PERIOD FROM 2011 TO 2015. IN ALL PATIENTS, AN ATTEMPT TO PERFORM TRANSMURAL DRAINAGE WAS MADE. THE PLACE OF THE TRANSMURAL TRACT WAS CHOSEN WITH EUS GUIDANCE. GASTROSTOMY(OR DUODENOSTOMY) WAS CREATED WITH THE USE OF GIOVANNINI CYSTOSTOME (CYSTOTOME CST-10, WILSON-COOK). THE FISTULA FORMED BETWEEN THE GASTROINTESTINAL LUMEN AND NECROTIC CAVITY WAS SEQUENTIALLY DILATED WITH AN 8 MM OR 20 MM BALLOON DILATOR (BOSTON SCIENTIFIC). A 7FR OR 8FR NASOCYSTIC DRAIN (BALTON OR WILSON-COOK) AND DOUBLE-PIGTAIL STENTS 7FR OR 8.5FR (ZSO-10-5, WILSON-COOK OR MAR FLOW) WERE DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT. WHEN THE MAIN PANCREATIC DUCT LEAK WAS OBSERVED, SPHINCTEROTOMY WAS PERFORMED WITH AN OLYMPUS FLOWCUT KD-301Q0725 SPHINCTEROTOME AND PANCREATIC STENT WAS PLACED (PASSIVE TRANSPAPILLARY DRAINAGE) TO BRIDGE THE LEAK¿5FR, 7FR, 8.5FR, OR 10FR (GEENEN, ZIMMON PANCREATIC STENT, WILSON-COOK MEDICAL INC. OR MAR FLOW) (FIGURES 1(A)¿1(C)). THE STENT WAS THEN REPLACED WITH A NEW ONE AFTER 6, 12, AND 24 MONTHS OR UNTIL THE PANCREATIC DUCT LEAK WAS NO LONGER DEMONSTRATED. THIS COMPLAINT WAS OPENED TO CAPTURE THE OFF LABEL USE OF THE ZSO STENT FOR WALLED-OFF PANCREATIC NECROSIS (WOPN). NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY.

    Description of Event or Problem · 0

    CANCELLATION REPORT BEING SUBMITTED AS THIS EVENT NO LONGER MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682398 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G21975 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown