BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 888334 · Received March 23, 2007

    Report

    Report Number
    6000078-2007-00086
    Event Type
    Death
    Date Received
    March 23, 2007
    Date of Event
    February 17, 2007
    Report Date
    February 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    H02002/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUCCESSFUL EMERGENT STENT AND COILING PROCEDURE IN 2007 OF A LARGE LEFT COROTID ANEURYSM "IMPENDING RUPTURE". THE PATIENT REPORTEDLY DID NOT RECEIVE ANTICOAGULANT THERAPY PRE-PROCEDURE AS INDICATED IN THE DIRECTIONS FOR USE (DFU) "TYPICAL ANTIPLATELET AND ANTICOAGULATION REGIMEN USED FOR INTERVENTIONAL INTRACRANIAL PROCEDURE IS RECOMMENDED AT THE DISCRETION OF THE TREATING PHYSICIAN" DUE TO IMPENDING ANEURYSMAL RUPTURE AND THE POSSIBLE TREATMENT OPTIONS, INCLUDING SAME DAY SURGERY. DESPITE THE IMMEDIATE USE OF IV HEPARIN BOLUS, REO-PRO BOLUS PLUS DRIP INFUSION; INTRA-ARTERIAL (IA) PHENYLPROPANOLINE (PPA), IA REO-PRO AND MERCI AFTER SUCCESSFUL STENT PLACEMENT; THE CAROTID ARTERY REPORTEDLY WAS TOTALLY THROMBOSED. THE PATIENT THEN DEVELOPED A MASSIVE LEFT HEMISPHERE STROKE AND FURTHER CARE WAS WITHDRAWN AT THE FAMILY'S REQUEST. THE PATIENT EXPIRED LATER THAT DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death