BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 3951829 · Received July 2, 2014

    Report

    Report Number
    3001845648-2014-00115
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K)#: K040505, K043481 AND K051124. FURTHER INFORMATION RECEIVED ON (B)(4) 2014 STATE THAT THE ZIB6 DEVICE WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION ON THIS HAS BEEN REQUESTED AND WILL BE SUBMITTED IN A FOLLOW UP REPORT. THE DEVICE INVOLVED IN THIS COMPLAINT IS: 1 X ZIB6-40-10-8.0 (LOT NO. C858178). THE STENT HAS NOT BEEN RETURNED TO THE MANUFACTURER HENCE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NO. C858178 OF ZIB6-40-10-8.0 DEVICES AND ASSOCIATED STENTS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ZILVER 635 BILIARY DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. IMAGES OF THE EVENT HAVE BEEN RECEIVED AND HAVE BEEN FORWARDED FOR CLINICAL REVIEW. ON RECEIPT OF THE IMAGE REVIEW, ANY RELEVANT ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW UP REPORT. FURTHER INFORMATION RECEIVED ON (B)(4)2014 STATE THAT THE ZIB6 DEVICE WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION ON THIS HAS BEEN REQUESTED AND WILL BE SUBMITTED IN A FOLLOW UP REPORT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS NOR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR ANY POTENTIAL TRENDS.

    Description of Event or Problem · 1

    INITIAL COMPLAINT DESCRIPTION RECEIVED STATED THAT: "THE PRODUCT WAS PROBABLY BROKEN WHILE USING. THE PHYSICIAN HAD TO PUT IN ANOTHER STENT (WALLSTENT) TO KEEP THE BILIARY DUCT OPEN. NO PROBLEMS OCCURRED THROUGH THE WHOLE PROCEDURE, APART FROM THE PROBLEM WITH THE ZIB6 DEVICE - WHEN THE PHYSICIAN DEPLOYED IT, IT LOOKED LIKE THAT THE ZIB6 WAS BROKEN AND/OR TWISTED." ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE NOR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. FURTHER INFORMATION RECEIVED ON (B)(4) 2014 STATE THAT THE ZIB6 DEVICE WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION ON THIS HAS BEEN REQUESTED AND WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386216 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C858178

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention