BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM 3 STENT DELIVERY SYSTEM

    MDR report key: 1112096 · Received August 6, 2008

    Report

    Report Number
    2939204-2008-00313
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Report Date
    July 12, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - FOR STENT HERNIATION INTO THE ANEURYSM. CURRENTLY, THERE ARE NO FURTHER DETAILS TO REPORT.

    Description of Event or Problem · 1

    AT A PEER REVIEW CONFERENCE, THE FOLLOWING EVENT WAS REPORTED. THE PT PRESENTED WITH VISION LOSS AND THE CAUSE WAS DETERMINED TO BE A LARGE, WIDE-CHECKED PARAOPHTHALMIC ANEURYSM. THE STENT SYSTEM WAS DELIVERED TO THE TARGET LESION, AND THE STENT WAS DEPLOYED WITHOUT ISSUE. HOWEVER, THE DISTAL PART OF THE STENT WAS NOTED TO BE PARTIALLY PROLAPSED INTO THE ANEURYSM. FOUR COILS WERE PLACED INTO THE ANEURYSM SUCCESSFULLY BUT THE FIFTH COIL WAS REPORTED TO BECOME CAUGHT. IT WAS NOT DISCLOSED WHAT THE COIL BECAME CAUGHT ON AND OR WHAT ACTION WAS TAKEN TO RELEASE THE COIL. TWO MONTHS POST PROCEDURE, A SECOND STENT (NON-BOSTON SCIENTIFIC) WAS PLACED ACROSS THE NECK OF THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 STENT DELIVERY SYSTEM (NJE) NEUROFORM STENT NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC TRANSEND GUIREWIRE| FIVE COILS| CORDIS ENTERPRISE STENT