BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 813151 · Received January 30, 2007

    Report

    Report Number
    6000078-2007-00023
    Event Type
    Injury
    Date Received
    January 30, 2007
    Date of Event
    December 14, 2006
    Report Date
    January 3, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS RETAINED BY THE USER FACILITY, THEREFORE, BOSTON SCIENTIFIC COULD NOT DETERMINE IF THE DEVICE FAILED TO MEET DEVICE, LABELING, OR PACKAGING SPECIFICATIONS. ACCORDING TO THE INFO PROVIDED BY THE USER FACILITY, THERE WAS EXCESSIVE FRICTION BETWEEN THE STABILIZER AND THE CATHETER. THIS DEVICE WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. BOSTON SCIENTIFIC COULD NOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IT IS POSSIBLE THAT THE OPERATOR ENCOUNTERED FRICTION WHEN ATTEMPTING TO DEPLOY THE STENT. IT IS UNCLEAR WHAT COULD HAVE POTENTIALLY CAUSED HIGH FRICTION DURING DEPLOYMENT. IT IS POSSIBLE THAT A HIGHLY TORTUOUS ANATOMY CAUSED RESISTANCE IN STENT DEPLOYMENT, OR THAT THERE WAS AN INADEQUATE FLUSH RUNNING THROUGH THE SYSTEM. IN ADDITION, EXCESSIVE FORCE MAY HAVE BEEN APPLIED BETWEEN THE STABILIZER AND THE CATHETER IN AN EFFORT TO DEPLOY THE STENT. HOWEVER, THERE WAS NOT ENOUGH EVIDENCE TO NARROW THESE OPTIONS DOWN. THE CAUSE OF THE EVENT REMAINS UNK. ADD'L PMA/510 (K): H020002/S5.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WHILE ATTEMPTING TO DEPLOY THE STENT IN QUESTION DURING A PROCEDURE, THE PUSHER STUCK IN THE CATHETER. THE PT REPORTEDLY REQUIRED MEDICAL INTERVENTION. THE USER FACILITY DID NOT DISCLOSE ANY OTHER INFO REGARDING THIS EVENT, INCLUDING THE PT'S FINAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM (NJE) INTRACRANIAL STENT NJE BOSTON SCIENTIFIC CORP, NEUROVASCULAR SNF34515 9153950

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention