BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 823249 · Received March 2, 2007

    Report

    Report Number
    6000078-2007-00066
    Event Type
    Injury
    Date Received
    March 2, 2007
    Date of Event
    February 1, 2007
    Report Date
    February 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV.
    Product Code
    NJE
    PMA / PMN Number
    h020002/s4,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURERS ONLY: MALFUNCTION OF THE DEVICE IN QUESTION INDIRECTLY CONTRIBUTED TO THE PHYSICIAN'S DECISION TO PLACE ANOTHER STENT TO COMPLETE THE PROCEDURE. THE DEVICE IN QUESTION WILL NOT BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION, AS IT IS IMPLANTED IN THE PATIENT. 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. THIS EVENT HAS BEEN INCLUDED IN AN EXISTING CAPA (CORRECTIVE AND PREVENTIVE ACTION) OPENED FOR EVENTS WITH SIMILAR OCCURRENCES. H020002/S5.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) ON 02/06/2007 THAT A CUSTOMER ENCOUNTERED PROBLEMS DURING USE OF A DETACHABLE COIL. ACCORDING TO THE CUSTOMER: "DURING THE PROCEDURE, THE STENT [DEVICE IN QUESTION] DEPLOYED PREMATURELY, RESULTING IN SUB OPTIMAL PLACING OF THE STENT [DEVICE IN QUESTION]. A SECOND [BSC] STENT OF THE SAME SIZE WAS PLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS. PATIENT STATUS IS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE: STENT (INTRACRANIAL NEUROVASCULAR) NJE BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV. SNF34020 7668807

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention