BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 4319739 · Received November 25, 2014

    Report

    Report Number
    3001845648-2014-00278
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 29, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO ANOTHER METAL BILIARY STENT/SET (EVOLUTION) DEVICE CURRENTLY MARKETED IN THE US. A SIMILAR METAL STENT/SET (EVOLUTION) DEVICE IS CURRENTLY MARKETED IN THE US UNDER THE FOLLOWING 510 (K) #: K121430. INCIDENT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR REMOVAL OF A PERMANENT STENT (DEPLOYMENT RELATED); REGARDLESS OF PT OUTCOME. OUT EVAL OF THE RETURNED DEVICE, IT WAS NOTED THAT THE LUER LOCK FITTING WITH THE SAFETY WIRE WAS RETURNED DETACHED FROM THE DEVICE. THE STENT WAS RETURNED FULLY DEPLOYED BUT STILL ATTACHED TO THE INTRODUCER AS IT WAS NOTED TO BE CAUGHT ON THE YELLOW MARKER. UPON FURTHER EXAMINATION IT WAS NOTED THAT THE YELLOW MARKER HAD AN INCOMPLETE SKIVE AND A SPLIT BETWEEN THE SKIVED LUMEN AND CARRIER LUMEN WAS PRESENT. DURING THE EVAL THE STENT WAS RELEASED FROM THE INTRODUCER. THERE WAS NO DAMGE NOTED TO THE STENT. THE COMPLAINT COULD BE CONFIRMED FROM THE PHOTOS PROVIDED OF THE DEVICE BY THE USER AND THE STENT WAS ALSO RETURNED FULLY DEPLOYED BUT REMAINED ATTACHED TO THE INTRODUCER. A POSSIBLE CAUSE OF THE STENT NOT DETACHING COULD BE IF THE SKIVE OF THE YELLOW MARKER WAS NOT TAPERED SUFFICIENTLY DURING THE MFR OF THE EVO-FC-10-11-6-B DEVICE. THE RELEVANT PERSONNEL HAVE BEEN NOTIFIED AND THIS COMPLAINT WILL BE INCLUDED IN A QUALITY AWARENESS TRAINING SESSION. HOWEVER, AS THE ACTUAL USE CONDITIONS COULD NOT BE REPLICATED IN THE LABORATORY WE CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THIS COMPLAINT. PRIOR TO DISTRIBUTION, ALL EVO-FC-10-11-6 B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR THE EVO-FC-10-11-6 B DEVICE OF LOT NUMBER C1034486 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. AS PER THE INSTRUCTIONS FOR USE, IFU0062-4, NOTES SECTION ADVISES THE USER OF THE FOLLOWING: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD INHIBIT PROPER WORKING CONDITION, DO NOT USE". FROM THE INFO PROVIDED THERE WERE NO ADVERSE EFFECTS TO THE PT REPORTED AS OCCURING. ANOTHER EVOLUTION DEVICE WAS USED TO COMPLETE THE PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS NOT POSSIBLE TO FULLY DEPLOY THE EVOLUTION BILIARY STENT IN THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO ADVERSE EFFECTS TO THE PT WERE REPORTED AS OCCURING AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766585 EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1034486

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST