BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ- 4.5 X 30MM

    MDR report key: 3122431 · Received May 21, 2013

    Report

    Report Number
    3008853977-2013-00156
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.  THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED.  HOWEVER, PATIENT OUTCOME OF DEATH, STROKE, AND HEMORRHAGE ARE NOTED AS SUCH IN THE DIRECTION FOR USE (DFU).  THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM LOCATED AT THE BASILAR ARTERY TIP. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. ON THE FOLLOWING DAY, THE PATIENT EXPERIENCED ISCHEMIC STROKE WITH SYMPTOMS OF VISUAL FIELD DEFECT AND ATAXIA (MODIFIED RANKIN SCALE: GRADE 2). HEPARIN (DOSAGE UNKNOWN) WAS ADMINISTERED. FOUR DAYS POST PROCEDURE, THE PATIENT EXPERIENCED A BRAIN STEM HEMORRHAGE WITH SYMPTOMS OF FULL PARALYSIS AND LETHARGY. NITROGLYCERIN (DOSAGE UNKNOWN) WAS ADMINISTERED. SEVEN DAYS POST PROCEDURE, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223736 NEUROFORM 3 EZ- 4.5 X 30MM STENT INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 15261565

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| O 6 COILS (MANUFACTURER UNKNOWN)| 7 TARGET COILS (STRYKER)