BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 19605511 · Received June 25, 2024

    Report

    Report Number
    3001845648-2024-00289
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 28, 2024
    Report Date
    September 2, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002219738
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    E1, F3 - COUNTRY: (B)(6). AN ADVERSE EVENT HAS BEEN REPORTED WITHOUT A DEVICE PROBLEM. A DEVICE MALFUNCTION WAS NOT REPORTED. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. DEVICE EVALUATION: 1 UNIT OF LOT NUMBER CF2116673 OF ZSO-10-3 DEVICE COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ZSO-10-3 ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ZSO-10-3 OF LOT NUMBER CF2116673 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER CF2116673. INSTRUCTIONS FOR USE AND/LABEL: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0045) WHICH INFORMS THE USER OF THE FOLLOWING POTENTIAL COMPLICATIONS THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0045). IMAGE REVIEW: IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER. IMPRESSION: 1. THE INDICATION FOR USING THE ZIMMON BILIARY STENT WAS NOT DISCUSSED, NOR WERE THE IMAGES FROM INITIAL PLACEMENT. 2. THE STENT MATERIAL WAS DESCRIBED AS "HARDER THAN PREVIOUS BATCHES" BY THE SURGEON AND THE NURSE. DESPITE THIS, THE STENT WAS STILL USED. THERE IS NO DISCUSSION OF ANY UNUSUAL CIRCUMSTANCES REGARDING THE PACKAGING OR STORAGE WERE NOTED. THE PRODUCT WAS NOT EXPIRED. 3. A FOLLOW UP ERCP 3 DAYS AFTER PLACEMENT DEMONSTRATED AN EROSIVE ULCER IN THE DUODENUM AT THE LOCATION WHERE THE END OF THE PIGTAIL ENGAGED WITH THE WALL OF THE DUODENUM. THIS ULCER WAS THOUGHT TO BE RELATED TO THE INCREASED HARDNESS OF THE STENT MATERIAL, LEADING TO INCREASED PRESSURE AND THUS AN EROSIVE ULCER DEVELOPED. WITHOUT THE PLACEMENT IMAGES, IT IS UNCERTAIN IF THE STENT WAS PLACED CORRECTLY, OR POTENTIALLY INCORRECTLY, WHICH MAY HAVE INCREASED THE PRESSURE/RUBBING OF THE STENT END ON THE DUODENAL WALL, WITH OR WITHOUT THE INCREASED HARDNESS. 4. THE REPORT ALSO DOES NOT STATE IF THE STENT WAS RETURNED, SO THE HARDNESS OF THE MATERIAL COULD BE EVALUATED. HAS COOK CHANGED THE FORMULATION OF THE MATERIAL? 5. GIVEN THE LOCATION OF THE BLEEDING ULCER, AND THE PROXIMITY TO THE END OF THE STENT, DESPITE NOT BEING DOCUMENTED ON THE IMAGES SUBMITTED FOR REVIEW, THE STENT IN ALL LIKELIHOOD CAUSED THE ULCER. WHETHER THIS WAS DUE TO THE PERCEIVED INCREASED HARDNESS OF THE MATERIAL, STENT MALPOSITION, PATIENT'S BIOLOGY, OR A COMBINATION OF ALL THESE FACTORS, CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KNOWN POTENTIAL PROCEDURAL COMPLICATIONS OR KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF THIS DEVICE. BASED ON THE MANUFACTURING REPORT, THERE WAS NO CHANGE IN THE MATERIAL. THE HARDNESS IN THE STENT MATERIAL COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED. THE ADVERSE EVENT 'ULCER' NOTICED IS A KNOWN ADVERSE EVENT AND IS COVERED UNDER SECTION POTENTIAL COMPLICATIONS OF THE IFU 'TRAUMA TO DUODENUM' AS CONFIRMED FROM THE MEDICAL ADVISOR. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED BLEEDING AT THE IMPLANTATION SITE THREE DAYS POST-PROCEDURE, WITH THE TIP OF THE PIGTAIL CATHETER MAKING CONTACT WITH THE WALL. AN ULCER WAS OBSERVED AT THE SITE OF CONTACT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KNOWN POTENTIAL PROCEDURAL COMPLICATIONS OR KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF THIS DEVICE. BASED ON THE MANUFACTURING REPORT, THERE WAS NO CHANGE IN THE MATERIAL. THE HARDNESS IN THE STENT MATERIAL COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED. THE ADVERSE EVENT 'ULCER' NOTICED IS A KNOWN ADVERSE EVENT AND IS COVERED UNDER SECTION POTENTIAL COMPLICATIONS OF THE IFU 'TRAUMA TO DUODENUM' AS CONFIRMED FROM THE MEDICAL ADVISOR

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: THE CASE WAS DONE ON 24 MAY, THE SURGEON AND NURSES RECALL THAT THE ZSO PLASTIC STENT IS MATERIALS IS HARDER THEN PREVIOUS BATCHES. AFTER 3 DAYS OF IMPLANTATION, SURGEON FOUND THE IMPLANTATION SITE IS BLEEDING AND THE TIP OF THE PIGTAIL ENGAGE TO THE WALL, ULCER WAS FOUND AT THE TOUCHING SITE. PATIENT OUTCOME: BLEEDING ULCER WAS FOUND. PATIENT/EVENT INFO - NOTES; BLEEDING ULCER WAS FOUND.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 02-SEP-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449077 ZIMMON BILIARY STENT FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK IRELAND LTD G21973 CF2116673 10827002219738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention