BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3972145 · Received July 31, 2014

    Report

    Report Number
    3008853977-2014-00227
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    April 30, 2011
    Report Date
    July 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MINN
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS, INCLUDING RELEVANT DEVICE HISTORY RECORDS (DHR) COULD NOT BE PERFORMED DUE TO THE WINGSPAN LOT NUMBER WAS NOT REPORTED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, HEMORRHAGE IS A KNOWN RISK ASSOCIATED WITH SUCH PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PATIENT COMPLICATION HAS BEEN ASSIGNED TO THE EVENT. THE SUBJECT DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL OF STROKE AND CEREBROVASCULAR DISEASES THAT THE STENT SYSTEM WAS ADVANCED AND THE STENT WAS DEPLOYED COVERING FOR THE ENTIRE LESION TO TREAT OF AN ACUTE ISCHEMIC STROKE. POST PROCEDURE THE PATIENT EXPERIENCED AN INTRACEREBRAL PARENCHYMAL HEMORRHAGE. THE PATIENT UNDERWENT THE PROCEDURE BETWEEN (B)(6) 2008 AND (B)(6) 2011, THE EXACT DATE OF THE PROCEDURE IS UNKNOWN. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447488 UNKNOWN_NEUROVASCULAR_PRODUCT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - MINN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other