BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3072057 · Received April 22, 2013

    Report

    Report Number
    3008853977-2013-00117
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    August 1, 2010
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, THROMBOSIS IS NOTED IN THE DIRECTION FOR USE (DFU). THEREFORE, THE PROBABLE CAUSE OF THE EVENT IS ANTICIPATED PATIENT COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. ALL PATIENTS WERE TREATED BETWEEN AUGUST 2001 AND AUGUST 2010.

    Description of Event or Problem · 1

    A LITERATURE ARTICLE IN NEURORADIOLOGY REPORTED THAT A RETROSPECTIVE STUDY WAS CONDUCTED ON PATIENTS TREATED WITH NEUROFORM STENTS BETWEEN AUGUST 2001 AND AUGUST 2010. IT WAS REPORTED THAT A THROMBOLIC EVENT OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    A LITERATURE ARTICLE IN NEURORADIOLOGY REPORTED THAT A RETROSPECTIVE STUDY WAS CONDUCTED ON PATIENTS TREATED WITH NEUROFORM STENTS BETWEEN AUGUST 2001 AND AUGUST 2010. IT WAS REPORTED THAT A THROMBOLIC EVENT OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171821 UNKNOWN_NEUROVASCULAR_PRODUCT STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other