BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 16973203 · Received May 22, 2023

    Report

    Report Number
    3001845648-2023-00385
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    January 15, 2020
    Report Date
    July 13, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    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/510(K) # K163018. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4) / MDR REF#3001845648-2023-00384 AND IT WAS CREATED FROM THE ATTACHED POST MARKET STUDY COMPLAINT FORM. MANUFACTURING RECORDS REVIEW. PRIOR TO DISTRIBUTION ALL ZILBS-635-10-6 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0065) LISTS CHOLANGITIS, SEPSIS AND STENT OCCLUSION AS POTENTIAL ADVERSE EVENTS. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. IMAGE REVIEW : AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. THE BILIARY SEPSIS REPORTED WAS RELATED TO CHOLANGITIS WHICH WAS SECONDARY TO AN OBSTRUCTED STENT. AS PREVIOUSLY NOTED, THE IFU LISTS CHOLANGITIS, SEPSIS AND STENT OCCLUSION AS POTENTIAL ADVERSE EVENTS. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AND/OR REP TESTIMONY. SUMMARY OF INVESTIGATION: THE COMPLAINT WAS RAISED VIA AN OBSERVATIONAL POST MARKET STUDY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED BILIARY SEPSIS 301 DAYS POST PROCEDURE. THE PATIENT REQUIRED THE PLACEMENT OF AN ADDITIONAL STENT DUE TO THIS OCCURRENCE. THE EVENT WAS CONSIDERED RESOLVED. INVESTIGATION FINDINGS CONCLUDE A POSSIBLE ROOT CAUSE OF KNOWN POTENTIAL COMPLICATIONS. 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))) MISCELLANEOUS: SEPSIS(BILIARY) Q5: DEVICE/PROCEDURE: CHOLANGITIS SECONDARY TO OBSTRUCTED STENT, PRE-EXISTING; PREVIOUS METAL SENT ASSOCIATE WITH CHOLANGITIS, Q7: NO. NOTE: SEPSIS (BILIARY). NOTE: 301 DAYS POST-PROCEDURE. NOTE: AE4. 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; UNDER ENDOSCOPIC AND FLUOROSCOPIC GUIDANCE A 10 MM X 8 CM COOK ZILVER UNCOVERED METAL STENT WAS PLACED IN THE BILE DUCT, 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

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-JUL-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808436 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention