BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 1033816 · Received April 24, 2008

    Report

    Report Number
    2939204-2008-00149
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    October 20, 2007
    Report Date
    March 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC - NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATE: UNK AS MODEL AND LOT # HAVE NOT BEEN DISCLOSED. THERE WERE NO ALLEGED MALFUNCTIONS ON THE PART OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2007 STENT PLACEMENT AND COILING OF THE PT'S RIGHT CAVERNOUS INTERNAL CAROTID ARTERY (ICA) ANEURYSM WAS COMPLETED WITHOUT INCIDENT. POST PROCEDURE, PT COMPLAINED OF HEADACHE AND HAD RIGHT EYE UPWARD GAZE PALSY. THE PT WAS TREATED WITH MEDICATION, OBSERVATION AND PROLONGED HOSPITALIZATION. PT WAS SUBSEQUENTLY DISCHARGED HOME THE FOLLOWING MONTH. OPHTHALMOLOGY EVAL STATED, THAT THE GAZE PALSY WAS DUE TO COMPRESSIVE CRANIAL NEUROPATHIES OF THE FORTH AND SIXTH CRANIAL NERVES AND WILL RESOLVE OVER TIME. UPDATE THE SAME MONTH STATED, "VISION HAS IMPROVED AND HEADACHES HAVE DECREASED. TWO MONTHS LATER, PT ADMITTED TO THE HOSPITAL WITH RIGHT HEMISPHERE STROKE WITH APHASIA, RIGHT AND LEFT FACIAL DROOP AND LEFT HAND NUMBNESS. PT RESTARTED ON PLAVIX 75 MG AND ASA 325 MG DAILY (WAS TAKING 81 MG/DAY). ANGIOGRAM CT SCAN AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) ARE NEGATIVE FOR THE SOURCE OF THE STROKE, HOWEVER, MRI SHOWS SUBACUTE ISCHEMIC INFARCT IN THE RIGHT PARIETAL LOBE. THE PT WAS DISCHARGED HOME THE SAME MONTH. UPDATE 2007 STATED, "ALL STROKE SYMPTOMS HAVE RESOLVED. ANGIOGRAPHY TAKEN TODAY WAS GOOD WITH ANEURYSM THROMBOSED AND NO STENOSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM (NJE) INTRAVASCULAR STENT NJE BOSTON SCIENTIFIC - NEUROVASCULAR DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R GDC COILS (AMOUNT USED| NOT DISCLOSED).| PLAVIX 75 MG AND ASA 325 DAILY