BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 4350949 · Received December 12, 2014

    Report

    Report Number
    3001845648-2014-00326
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    October 23, 2014
    Report Date
    December 1, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K)#: K040505, K043481 AND K051124. A 1X ZIB6-40-10.6.0 DEVICE OF LOT NUMBER C871355 WAS RETURNED TO COOK IRELAND FOR EVAL. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. ON EVALUATION OF THE RETURNED DEVICE, IT HAS BEEN CONFIRMED THAT THE STENT HAD BEEN DEPLOYED. IT WAS NOTED THAT THE STENT IN QUESTION WAS NOT RETURNED AND ONLY THE DELIVERY SYSTEM WAS AVAILABLE FOR EVAL. THE LENGTH OF THE OUTER SHEATH WAS MEASURED AND NOTED TO BE AS PER SPECIFICATION. THERE WAS NO TACTILE DAMAGE OR DEFORMATION TO THE OUTER SHEATH. USING 1ML OF WATER, THE DEVICE WAS FLUSHED THROUGH THE HANDLE HUB PORT WITH NO DIFFICULTIES. DELIVERY SYSTEM COULD BE ADVANCED OVER THE 0.035" WIRE GUIDE WITH NO ISSUES NOTED. DISTAL END OF THE INNER CATHETER WAS VISUALLY EXAMINED. NO EXCESS GLUE AND NO DAMAGE OR INDENTATION WAS EVIDENT ON THE EDGE OF THE PUSHER RING. UPON EXAMINATION OF THE RETURNED DEVICE IT CAN BE STATED THAT THE DEVICE WAS MANUFACTURED CORRECTLY AND THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE HAS MALFUNCTIONED. IT MAY BE NOTED THAT THE FOLLOWING INFO WAS PROVIDED BY THE COMPLAINT ORIGINATOR" THE SIZE OF STENT WAS TOO SMALL, SO THE STENT MIGRATED BELOW THE LESION SITE AFTER IT WAS DEPLOYED" AND ALSO: 'THE PHYSICIAN KNEW THAT IT WAS NOT THE CORRECT SIZE DURING THE PROCEDURE..." AS THERE WERE NO IMAGES AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. BASED ON THE AVAILABLE INFO THE CAUSE OF THIS COMPLAINT CAN BE ATTRIBUTED TO USER ERROR. THE USER SELECTED INCORRECT STENT SIZE FOR THE PROCEDURE WHICH RESULTED IN STENT MIGRATION. THE FOLLOWING INFO IS INCLUDED IN THE INSTRUCTION FOR USE, SECTION 'SELECTION OF STENT': "MEASURE THE LENGTH OF THE TARGET STRICTURE TO DETERMINE THE LENGTH OF THE STENT REQUIRED. ALLOW FOR THE AREA PROXIMAL AND DISTAL TO THE TUMOR TO BE COVERED WITH THE STENT TO PROTECT AGAINST INTERFERENCE FROM FURTHER TUMOR INGROWTH. MEASURE THE DIAMETER OF THE REFERENCE LUMEN (PROXIMAL AND DISTAL TO THE STRICTURE) AND REFER TO STENT SIZE SELECTION TABLE". PRIOR TO DISTRIBUTION, ALL ZIB6-40-10.6.0 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MFG RECORDS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    DURING A ZILVER BILIARY STENT PLACEMENT PROCEDURE THE DOCTOR FAILED TO MEASURE THE STENT SIZE CORRECTLY. THE STENT WAS DEPLOYED BUT THE LENGTH OF THE STENT WAS TOO SHORT AND THE STENT MIGRATED. THE STENT WAS REPLACED WITH ANOTHER DEVICE. NO ADVERSE EFFECTS TO THE PT HAVE BEEN REPORTED AS OCCURRING AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808190 ZILVER 635 SELF-EXPANDING BILIARY STENT CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C871355

    Patients

    Seq Age Sex Outcome Treatment
    1 NA