BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM 3 MICRODELIVERY STENT SYSTEM

    MDR report key: 1003235 · Received February 21, 2008

    Report

    Report Number
    2939204-2008-00053
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    December 5, 2007
    Report Date
    January 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND SIMILAR COMPLAINT REVIEW WAS PERFORMED AND NO ISSUE OR DISCREPANCIES WERE FOUND. THE DHR REVIEW SHOWED THAT THE BATCH MET ALL REQUIRED SPECIFICATIONS UPON ITS RELEASE AND NO ADVERSE TRENDS WERE OBSERVED. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE MICRODELIVERY CATHETER PROXIMAL OUTER SHAFT WAS KINKED AT 1.0CM AND 28.0CM DISTAL TO THE STRAIN RELIEF. THE STABILIZER WAS RETURNED JAMMED INSIDE THE MICRODELIVERY CATHETER WITH 4.5CM OF THE STABILIZER'S DISTAL SECTION PROTRUDING THROUGH THE MICROCATHETER'S DISTAL END. EFFORTS MADE TO REMOVE THE STABILIZER WERE NOT SUCCESSFUL AS THE STABILIZER APPEARED TO BE KINKED TOGETHER WITH MICRODELIVERY CATHETER. THE STABILIZER'S DISTAL LUMEN WAS CHECKED UNDER MAGNIFICATION, NO ANOMALIES WERE OBSERVED. THE FUNCTIONAL EVAL COULD NOT BE PERFORMED DUE TO THE ANOMALIES FOUND ON THE PRODUCTS. THE STENT WAS NOT RETURNED AS IT REMAINS IMPLANTED. BASED ON THE INFO PROVIDED AND ANALYSIS OF THE DEVICE, THE ROOT CAUSE FOR THE OBSERVED DAMAGE TO THE STENT AND THE STENT DELIVERY SYSTEM HAS BEEN DETERMINED TO BE "OPERATIONAL CONTEXT" AS THE PRODUCT MET SPECIFICATIONS EXCLUDING THOSE AREAS WHERE DAMAGE OCCURRED. IT IS OF NOTE THAT THE EVENT DESCRIPTION STATES THAT THE "MICROCATHETER" WAS ADVANCED AFTER THE STENT HAS BEEN FULLY DEPLOYED. WHILE THE INTENTION OF THE MICROCATHETER ADVANCEMENT AFTER DEPLOYMENT WAS NOT CLEAR FROM THE INFO PROVIDED. THE DFU DOES STATE THAT "AFTER THE SENT IS FULLY DEPLOYED, REMOVE THE DELIVERY SYSTEM." IN ADDITION, THE DFU INCLUDES PRECAUTIONS THAT STATE, "...THE NEUROFORM MICRODELIVERY STENT SYSTEM SHOULD NOT BE USED FOR REPOSITIONING OR RECAPTURING THE STENT." "...EXERCISE CAUTION WHEN CROSSING THE DEPLOYED STENT WITH ADJUNCT DEVICES." ALTHOUGH THE INTENTION OF THE ADVANCEMENT IS NOT CLEAR AND IS NOT IN DIRECT CONFLICT WITH THE DFU, IT IS POSSIBLE THAT THE CONTINUED MANIPULATION OF THE STENT SYSTEM ITSELF FOLLOWING DEPLOYMENT OF THE STENT MAY HAVE BEEN A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    DURING A PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA), FRICTION WAS REPORTEDLY FELT WHILE ADVANCING THE MICROCATHETER AND GUIDEWIRE THROUGH THE IMPLANTED STENT OF A PT WITH MILD VESSEL TORTUOSITY, WHEN ONE OF THE STENT STRUTS BECAME LODGED INSIDE THE TIP OF THE CATHETER, AND BROKE OFF FULLY CONTAINED WITHIN THE CATHETER. THE PHYSICIAN REMOVED THE CATHETER CONTAINING THE STRUT AND FINISHED THE PROCEDURE WITH COILING. THE PHYSICIAN REPORTEDLY FELT THAT THE STENT HAD NOT MALFUNCTIONED. THERE WAS NO ALLEGATION OF PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 MICRODELIVERY STENT SYSTEM NEUROVASCULAR STENT NJE BOSTON SCIENTIFIC SNF34520 9544881

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR