BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3072052 · Received April 22, 2013

    Report

    Report Number
    3008853977-2013-00113
    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

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. ALL PATIENTS WERE TREATED BETWEEN (B)(6) 2001 AND (B)(6) 2010. SUBJECT DEVICE IS NOT AVAILABLE.

    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.

    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 (B)(6) 2001 AND (B)(6) 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
    171537 UNKNOWN_NEUROVASCULAR_PRODUCT STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other