BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 MICRODELIVERY STENT SYSTEM

    MDR report key: 1221043 · Received November 4, 2008

    Report

    Report Number
    2939204-2008-00549
    Event Type
    Death
    Date Received
    November 4, 2008
    Date of Event
    May 5, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NO ALLEGATION OF DEVICE MALFUNCTION OR NON CONFORMANCE. ADDITIONAL INFO REGARDING THE EVENT WAS REQUESTED AND THE FOLLOWING WAS DETERMINED: THERE WERE NO DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE PT'S POST PROCEDURE COMPLICATIONS. THE CONTINUOUS FLUSH WITH HEPARINIZED SALINE SOLUTION WAS MAINTAINED DURING THE PROCEDURE. IN THE PHYSICIAN OPINION, THE COMPLAINT CAUSALLY WAS NOT RELATED TO A BOSTON SCIENTIFIC DEVICE. THE PHYSICIAN DID NOT ALLEGE ANY MALFUNCTION OF ANY DEVICE FOR THIS PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A RUPTURED ANEURYSM AT THE ANTERIOR CEREBRAL ARTERY (ACA). A STENT ASSISTED ANEURYSM COILING PROCEDURE WAS SUCCESSFULLY COMPLETED. A POST PROCEDURE IMAGING REVEALED THROMBOSIS WITH TOTAL OCCLUSION OF THE ACA. THE PT SUFFERED A RIGHT SIDED HEMIPARESIS AND APHASIA. IT WAS REPORTED THE PT HAS NOT REC'D ANY ADDITIONAL INTERVENTION AS A RESULT OF THE POST-PROCEDURAL COMPLICATIONS. THE PT WAS DISCHARGED FROM THE HOSP, AND EXPIRED LATER, THE DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 MICRODELIVERY STENT SYSTEM (NJE) STENT INTRACRANIAL NJE BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION E335020 9457683

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death MICROPLEX COILS (MODEL AND MANUFACTURER UNKNOWN)| ASPIRIN| PLAVIX (DOSE UNKNOWN)