BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM 3 - 2.5 X 20MM

    MDR report key: 3072059 · Received April 22, 2013

    Report

    Report Number
    3008853977-2013-00126
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. SUBJECT DEVICE WAS IMPLANTED.

    Description of Event or Problem · 1

    A LITERATURE ARTICLE REPORTED THAT DUE TO THE ANEURYSM SIZE OF THE PATIENT, A STENT WAS IMPLANTED PRIOR TO COIL EMBOLIZATION. POST STENT DEPLOYMENT, THE PHYSICIAN OBSERVED OVERLAP OF THE STENT DISTAL MARKERS SUGGESTING THAT THE STENT DID NOT FULLY EXPAND. THE DISTAL FLOW REMAINED STABLE WITHOUT REMARKABLE CHANGE AND THE ANEURYSM WAS EMBOLIZED WITHOUT DIFFICULTIES. THE DISTAL MARKERS DID NOT EXPAND PROPERLY DURING THE COIL EMBOLIZATION; HOWEVER, THE PHYSICIAN DID OBSERVE UNEXPECTED EXPANSION OF THE DISTAL MARKER ON ANGIOGRAPHY WHEN COILING WAS COMPLETED. DISTAL SUBTRACTED ANGIOGRAPHY SHOWED GOOD DISTAL FLOW, AND THE SHAPE OF THE COIL WAS NOT DISTORTED. THE PATIENT WAS DISCHARGED 14 DAYS AFTER ADMISSION WITHOUT ANY NEUROLOGICAL DEFICIT. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172563 NEUROFORM 3 - 2.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR EXCELSIOR SL-10 (BOSTON SCIENTIFIC)