BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    MDR report key: 15345048 · Received September 2, 2022

    Report

    Report Number
    3001845648-2022-00606
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    July 29, 2022
    Report Date
    December 16, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002314396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # - K182980. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # - K182980. DEVICE EVALUATION: THE ZIB5-125-4.0-40 DEVICE OF LOT NUMBER C1882525 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW : AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE LIMITED INFORMATION. POSSIBLE ROOT CAUSES COULD BE ATTRIBUTED TO THE DEVICE HANDLING TECHNIQUES BY THE USER OR POSSIBLY THE PATIENTS PRE EXISTING CONDITION OR ANATOMY THAT MAY HAVE CAUSED RESISTANCE TO BE ENCOUNTERED WHEN ATTEMPTING TO DEPLOY. THREE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION TO INVESTIGATE THIS COMPLAINT BUT UNFORTUNATELY THE ADDITIONAL INFORMATION WAS NOT RECEIVED. SHOULD THIS INFORMATION BECOME AVAILABLE IN THE FUTURE, THE FILE WILL BE REOPENED, RE-INVESTIGATED AND AMENDED IF NEED BE. CLARIFICATION ON WHAT WAS MEANT BY THE STENT WOULD NOT DEPLOY WAS RECEIVED ON 30 NOV 2022. WHEREBY IT WAS CLARIFIED THAT THE STENT COULD NOT BE DEPLOYED FROM THE INTRODUCER. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A MALE PATIENT OF UNSPECIFIED AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE ZILVER 518 BILIARY SELF-EXPANDING STENT, G31439, WAS USED. THE STENT AND CATHETER WAS FLUSHED AND ONCE THE PRODUCT WAS OVER THE WIRE, INTRODUCED INTO PATIENT AND READY TO DEPLOY, THEY [THE END USER] CLAIM THE STENT WOULD NOT OPEN. THEY [THE END USER] REMOVED THE PRODUCT AT THIS TIME. REQUESTED 11AUG2022. TH 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

    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 16-DEC-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575010 ZILVER 518 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G31439 C1882525 10827002314396

    Patients

    Seq Age Sex Outcome Treatment
    1 Male