BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 2 MICRODELIVERY STENT SYSTEM

    MDR report key: 1221024 · Received November 4, 2008

    Report

    Report Number
    2939204-2008-00550
    Event Type
    Death
    Date Received
    November 4, 2008
    Date of Event
    December 18, 2006
    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

    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. THERE WERE NO PROCEDURAL COMPLICATIONS. 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 PHYSICIAN SUCCESSFULLY COMPLETED THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOMA) STENT ASSISTED ANEURYSM COILING PROCEDURE. THE PATIENT REPORTEDLY SUFFERED A MASSIVE RIGHT FRONTAL LOBE INFARCTION THREE DAYS AFTER THE PROCEDURE. THE PHYSICIAN STATED THAT THE PT DID NOT RECEIVE 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 2 MICRODELIVERY STENT SYSTEM (NJE) STENT INTRACRANIAL NJE BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death MICROPLEX COILS| HYDROCOIL COILS (MODEL AND MFR UNKNOWN)