BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 10217472 · Received July 1, 2020

    Report

    Report Number
    3001845648-2020-00378
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 3, 2020
    Report Date
    September 7, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002506241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K163018. DEVICE EVALUATION: THE ZILBS-635-10-8 DEVICE OF LOT NUMBER C1628174 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 27 AUGUST 2020. ON EVALUATION OF THE DEVICE IT WAS OBSERVED THAT THE STENT HAD PARTIALLY PREMATURELY DEPLOYED. THE RED SAFETY TAB WAS IN PLACE ON DEVICE RETURN. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZILBS-635-10-8 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS 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 ZILBS-635-10-8 OF LOT NUMBER C1628174 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 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 C1628174. THE INSTRUCTIONS FOR USE (IFU0065-3) STATES THE FOLLOWING: ¿WITH THE ELEVATOR OPEN, CONTINUE ADVANCING THE DEVICE IN SHORT INCREMENTS UNTIL IT IS ENDOSCOPICALLY VISUALISED EXITING THE DUODENOSCOPE.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF THE USER NOT READING AND/OR FOLLOWING THE IFU WAS IDENTIFIED IN THE LABORATORY. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE ELEVATOR OF THE ENDOSCOPE WAS ¿PARTIALLY UP¿ DURING ADVANCEMENT OF THE DEVICE. THIS MAY HAVE RESULTED IN COMPRESSION OF THE OUTER SHEATH AND/OR RESISTANCE AS THE DEVICE WAS ADVANCED RESULTING IN PARTIAL PREMATURE DEPLOYMENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE USER REMOVED THE COMPLAINT DEVICE AND COMPLETED THE PROCEDURE WITH ANOTHER ZILVER STENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ADDITIONAL INFO RECEIVED 16-JUN-2020: 1. CAN I CONFIRM THAT THE COMPLAINT ISSUE WITH YOU PLEASE? DOES THIS MEAN THE USER COULD NOT DEPLOY OR RELEASE THE STENT FROM THE DELIVERY SYSTEM OR DOES IT MEAN THAT THE STENT DID NOT EXPAND UPON DEPLOYMENT INSIDE THE PATIENT? - AFTER PARTIAL DEPLOYMENT STENT WAS NOT RELEASED FROM THE DELIVERY SYSTEM . 2. IF IT MEANS THE STENT DID NOT EXPAND OR OPEN INSIDE THE PATIENT, PLEASE INDICATE IF THE STENT EVENTUALLY OPENED? ..NO ..ONLY PARTIALLY OPENED INSIDE THE PATIENT 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES OR INTERVENTIONS AS A RESULT OF THIS EVENT? - NO ADDITIONAL PROCEDURE WAS REQUIRED , THE PROCEDURE WAS COMPLETED WITH ANOTHER ZILVER STENT ADDITIONAL INFO RECEIVED 22-JUN-2020: "ONLY PARTIAL EXPANSION HAPPENED AND THEY TOOK OUT THE STENT FROM THE PATIENT AND COMPLETED THE PROCEDURE WITH ANOTHER ZILVER 635".

    Description of Event or Problem · 0

    ONE ZILVER 635 STENT WAS NOT ABLE TO OPEN DURING THE PROCEDURE AFTER THE CANNULATION DONE USING ULTRATOME, A TERUMO WAS USED TO CROSS THE STRICTURE , ONCE THE WIRE WAS CROSSED THEY EXCHANGED THE TERUMO WITH VIZIGLIDE EXCHANGE WIRE ADDITIONAL INFO RECEIVED 22-JUN-2020: "ONLY PARTIAL EXPANSION HAPPENED AND THEY TOOK OUT THE STENT FROM THE PATIENT AND COMPLETED THE PROCEDURE WITH ANOTHER ZILVER 635".

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE ZILVER 635 STENT WAS NOT ABLE TO OPEN DURING THE PROCEDURE AFTER THE CANNULATION DONE USING ULTRATOME, A TERUMO WAS USED TO CROSS THE STICTURE, ONCE THE WIRE WAS CROSSED THEY EXCHANGED THE TERUMO WITH VIZIGLIDE EXCHANGE WIRE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683304 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G50624 C1628174 10827002506241

    Patients

    Seq Age Sex Outcome Treatment
    1