BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 837384 · Received February 16, 2007

    Report

    Report Number
    6000078-2007-00055
    Event Type
    Malfunction
    Date Received
    February 16, 2007
    Date of Event
    January 23, 2007
    Report Date
    January 23, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510 (K): H020002/S5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO PLACE A STENT ACROSS THE NECK OF A GIANT CAVERNOUS INTERNAL CAROTID ARTERY (ICA) ANEURYSM FOR COILING. THE STENT SYSTEM WAS ADVANCED ACROSS THE NECK, BUT THE STENT COULD NOT BE DELIVERED. THE STENT HAD BEEN ADVANCED WITH THE USE OF A 300CM FLOPPY GUIDEWIRE. WHEN THE ATTEMPT WAS MADE TO DRAW BACK THE DELIVERY CATHETER, IT WAS DISCOVERED THAT THE STENT WAS NOT BEING UNSHEATHED. IT WAS FELT THAT THE STABILIZER WAS NOT LONG ENOUGH TO REACH THE END OF THE DELIVERY SYSTEM, AND THAT A FAIR AMOUNT OF FRICTION HAD BEEN FELT. UPON REMOVAL OF THE SYSTEM, IT WAS SEEN THAT THE 3 FRENCH DELIVERY CATHETER HAD BROKEN ABOUT 10 CMS FROM THE HUB ALONG THE CATHETER, AND THUS WOULD NOT DRAW BACK IN ORDER TO DELIVER THE STENT. THE ENTIRE STENT SYSTEM WAS DISCARDED. IT WAS REPORTED THE WIRE HAVE BEEN KINKED IN HANDLING, WHICH MAY HAVE CAUSED SOME FRICTION. A THIRD SYSTEM WAS PREPPED, POSITIONED ALONG A .012 WIRE, AND AGAIN THE DELIVERY CATHETER STRETCHED. THE STENT WAS WELL POSITIONED, SO THEY WERE ABLE TO PLACE THE STENT BY USING A . 018 WIRE AS THE STABILIZER. THE ANEURYSM WAS COILED TO THE PHYSICIAN'S SATISFACTION AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PATIENT WAS REPORTED TO BE FINE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM (NJE) INTRACRANIAL STENT NJE NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP. SNF34030 8517408

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR GDC 360 COILS| TRANSCEND FLOPPY GUIDEWIRE 300CM| THRUWAY WIRE .018| HEADLINER WIRE .012| 3 FRENCH DELIVERY CATHETER (MODEL/LOT NUMBER UNK)