BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 16973230 · Received May 22, 2023

    Report

    Report Number
    3001845648-2023-00386
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    March 11, 2019
    Report Date
    October 5, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA 510K # K163018. THIS FILE WAS CREATED FROM PMCF STUDY TO CAPTURE STENT FRACTURE. USER/USE RELATED COMPLAINTS IS CONSIDERED FORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. DEVICE EVALUATION: THE ZILBS-635-10-8 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL ZILVER 635 BILIARY SELF EXPANDING METAL STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. INSTRUCTIONS FOR USE/LABEL IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0065) STATES THE FOLLOWING: ¿THIS DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. FROM THE AVAILABLE INFORMATION, IT IS KNOWN THAT THE STENT WAS BEING PLACED THROUGH THE SIDE WALL OF A PREVIOUSLY PLACED STENT. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU/LABEL. FROM THE AVAILABLE INFORMATION, IT IS KNOWN THAT THE STENT WAS BEING PLACED THROUGH THE SIDE WALL OF A PREVIOUSLY PLACED STENT, SUBSEQUENTLY CAUSING ISSUES REPORTED. IT MAY BE NOTED THAT THE PRESENCE OF A PREVIOUSLY DEPLOYED STENT COULD HAVE CAUSE THE NEW STENT TO GET CAUGHT AND THE STENT STRUT TO PROTRUDE FROM THE OUTER CATHETER. IT IS LIKELY THAT THIS WOULD HAVE ALSO CAUSED A HIGH FORCE TO BE EXERTED ON THE DELIVERY SYSTEM THUS CAUSING THE OUTER SHEATH TO BECOME SEPARATED/BROKEN. AS PER COMPLAINT DESCRIPTION "DEVICE ISSUE: STENT FRACTURE, RELATIONSHIP; CASUAL RELATIONSHIP, CATHETER BROKE OFF AND REMOVED; PROCEDURE: NOT RELATED; PRE-EXISTING: NOT DOCUMENTED; DEFICIENCY: YES, CATHETER BROKE OFF " CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY: ACCORDING TO THE INITIAL REPORTER, (B)(4) ((B)(6)) STENT FRACTURE. CONFIRMED QUANTITY OF (B)(4) DEVICE, CONFIRMED USED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ACCORDING TO THE INITIAL REPORTER, STATUS: RESOLVED; TREATMENT: SURGICAL; CATHETER BROKE OFF AND REMOVED, DEATH: NO INVESTIGATION FINDINGS CONCLUDE THAT THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU/LABEL. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA OBSERVATIONAL POST MARKET STUDY COMPLAINT FORM "(DM: THE PARAMETERS/DATA POINTS THAT TRIGGERED THE REPORT. PULL DATA PROVIDED IN FROM AE & OTHER EVENTS LOG QUESTIONS ((Q3 EVENT CATEGORY), (Q5 EVENT RELATIONSHIP (STUDY DEVICE, STUDY PROCEDURE, PRE-EXISTING) AND (Q7 DEVICE DEFICIENCY))). DEVICE ISSUE: STENT FRACTURE, RELATIONSHIP; CASUAL RELATIONSHIP, CATHETER BROKE OFF AND REMOVED; PROCEDURE: NOT RELATED; PRE-EXISTING: NOT DOCUMENTED; DEFICIENCY: YES, CATHETER BROKE OFF. NOTE: 0 DAYS POST-PROCEDURE. STENT PLACED THROUGH THE WALL OF A PRE-EXISTING STENT. NOTE: AE1. PATIENT OUTCOME: (DM PULL DATA PROVIDED FROM AE & OTHER EVENTS LOG ((QUESTION 1 EVENT STATUS), (QUESTION 4 EVENT TREATMENT), (QUESTION 6 LEAD TO DEATH))) STATUS: RESOLVED; TREATMENT: SURGICAL; CATHETER BROKE OFF AND REMOVED, DEATH: NO. PATIENT/EVENT INFO - NOTES: NO MANUFACTURE ADDITIONAL QUESTIONS TO BE ASKED AS THIS IS A PMCF STUDY COMPLAINT.

    Description of Event or Problem · 0

    SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 05-OCT-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816444 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention