BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3990445 · Received August 7, 2014

    Report

    Report Number
    3008853977-2014-00242
    Event Type
    Injury
    Date Received
    August 7, 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

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ALTHOUGH THE PRODUCT WAS NOT RETURNED, THE REPORTED EVENT WAS CONFIRMED BASED ON THE INFORMATION AVAILABLE. THERE IS NO INDICATION FROM THE INFORMATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATION NONCONFORMANCE. THERE IS ALSO NO INDICATION OF MISUSE, USER ERROR OR MISHANDLING WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THE WINGSPAN DEVICE MALFUNCTIONED. THE REPORTED PATIENT HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DEVICE DFU (DIRECTIONS FOR USE). THEREFORE, A ROOT CAUSE OF ANTICIPATED PATIENT COMPLICATION WAS ASSIGNED TO THIS EVENT. SUBJECT DEVICE IS NOT AVAILABLE.

    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 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
    464304 UNKNOWN_NEUROVASCULAR_PRODUCT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - MINN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other