BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 842172 · Received April 26, 2007

    Report

    Report Number
    6000078-2007-00120
    Event Type
    Malfunction
    Date Received
    April 26, 2007
    Date of Event
    February 27, 2007
    Report Date
    February 27, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION DEPLOYED WITHOUT DIFFICULTY. NO DEFECTS WERE FOUND ON THE STENT AND MICRODELIVERY CATHETER COMPONENTS OF THE DEVICE IN QUESTION. PMA/510 (K) #:H020002/S5. THE DEVICE IN QUESTION (STENT) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW, SIMILAR COMPLAINTS REVIEW, INITIAL CONDITION EXAM, VISUAL/MICROSCOPIC EXAM, DIMENSIONAL CHECK AND FUNCTIONAL CHECK WAS PERFORMED AS PART OF THE DEVICE EVALUATION. THE DHR REVIEW FOUND ONE NONCONFORMANCE, DEEMED UNRELATED, CONFIRMING THAT THIS DEVICE MET ALL REQUIRED SPECIFICATIONS. THE SIMILAR COMPLAINTS REVIEW REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN REPORTED ON THIS BATCH. THE DEVICE IN QUESTION WAS RETURNED IN ITS POUCH. VISUAL /MICROSCOPIC EXAMINATION REVEALED THAT THE STENT WAS LOADED IN THE MICRODELIVERY CATHETER. THE STABILIZER HAD SEPARATED AT ITS PROXIMAL JUNCTION; THE REMAINING PORTION WAS NOT RETURNED. NO DEFECTS WERE OBSERVED ON THE STENT AND MICRODELIVERY CATHETER. MEASURABLE DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATIONS. IN THE FUNCTIONAL CHECK, THE STENT WAS DEPLOYED WITHOUT DIFFICULTY. BECAUSE THE COMPLAINT RATE FOR THE REPORTED ISSUE HAS EXCEEDED THE LEVELS DETAILED IN THE RISK MANAGEMENT DOCUMENTATION FOR THIS PRODUCT, A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE AND ADDRESS THE ISSUE. BASED ON THE FACTS AND FINDINGS, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2007, THAT "DURING THE PROCEDURE, THE STENT WAS MISDEPLOYED." CLARIFICATION RECEIVED ON APRIL 2, 2007: THE ANATOMY WAS VERY TORTUOUS. BEFORE GETTING THE DEVICE (STENT) TO THE TARGET SITE, ENERGY HAD BUILT UP IN THE SYSTEM. WHILE TRYING TO GET THE DEVICE TO THE TARGET SITE, THE PHYSICIAN INADVERTENTLY BUMPED THE DEVICE, AND AS A RESULT TO THE TENSION BUILT IN THE SYSTEM, THE STENT STARTED TO DEPLOY. ONLY THE DISTAL PORTION OF THE STENT WAS SEEN STARTING TO OPEN, AS THE REST OF THE STENT WAS STILL IN THE MICRODELIVERY CATHETER. THE PHYSICIAN IMMEDIATELY WITHDREW THE STENT SYSTEM WITHOUT COMPLICATION. THE PATIENT SUFFERED NO ADVERSE EFFECTS AND COMPLICATIONS FROM THIS AND IS FINE. THE PHYSICIAN PUSHED THE PARTIALLY DEPLOYED STENT BACK INTO THE MICRODELIVERY CATHETER OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM INTRACRANIAL, NEUROVASCULAR STENT NJE NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION SNF33520 9269528

    Patients

    Seq Age Sex Outcome Treatment
    1 YR GUIDEWIRE (UNKNOWN MFR)