BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM3 MICRODELIVERY STENT SYSTEM

    MDR report key: 845155 · Received May 1, 2007

    Report

    Report Number
    6000078-2007-00123
    Event Type
    Malfunction
    Date Received
    May 1, 2007
    Date of Event
    April 3, 2007
    Report Date
    April 3, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM: STENT [DEVICE IN QUESTION] PREMATURELY DEPLOYED PROXIMAL TO THE ANEURYSM. PT IS SCHEDULED TO COMPLETE THE PROCEDURE AT A LATER DATE. G5: H020002/S5. THE DEVICE IN QUESTION WILL NOT BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION AS IT REMAINS IMPLANTED IN THE PT. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED ON THE RELATED LOT [OF THE DEVICE IN QUESTION] AND NO YIELD OR COMPONENT ISSUES THAT ARE RELEVANT TO THIS EVENT WERE IDENTIFIED AT THE TIME OF MANUFACTURE. THE RELATED LOT HAD MET ALL REQUIRED SPECIFICATIONS, AND PASSED ALL VISUAL INSPECTIONS. A SEARCH IN THE COMPLAINT DATABASE WAS PERFORMED AND NO OTHER COMPLAINT HAS BEEN REPORTED FOR THE RELATED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THE STENT WAS PREMATURELY DEPLOYED PROXIMAL TO THE ANEURYSM. THE FOLLOWING INFO WAS REPORTED TO THE MANUFACTURER: "THE PT HAD EXTREMELY TORTUOUS ANATOMY. FRICTION BUILT UP ON THE GUIDEWIRE. THE GUIDEWIRE MOVED BACK AND THE STENT WAS INADVERTENTLY DEPLOYED OUT OF THE DELIVERY SYSTEM. PT WILL RETURN FOR COMPLETE PROCEDURE AT A LATER DATE. NO PT HARM WAS REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM3 MICRODELIVERY STENT SYSTEM STENT (INTRACRANIAL NEUROVASCULAR) NJE NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION SNF 34530 9238577

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR XELERATOR 300 GUIDEWIRE