BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT

    MDR report key: 1913905 · Received December 3, 2010

    Report

    Report Number
    2939204-2010-01132
    Event Type
    Injury
    Date Received
    December 3, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. RESTENOSIS IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    LITERATURE: COSTALAT ET AL, NEUROSURGERY 2010: 67(6); 1505-15 - ATTACHMENT: [2939204-2010-01132_MALDONADO_NEUROSURGERY_DEC2010.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT HAD AN ASYMPTOMATIC 60% RESTENOSIS. THE TRANSCRANIAL DOPPLER SCAN SHOWED AN INCREASED SYSTOLIC VELOCITIES UPT OT 300CM/S IN THE MIDDLE CEREBRAL ARTERY M1 SEGMENT. NO TREATMENT WAS PERFORMED AND AN ANGIOGRAM ONE YEAR LATER SHOWED THE LESION TO BE STABLE. THE MODIFIED RANKIN SCORE REMAINED UNCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT HAD AN ASYMPTOMATIC 60% RESTENOSIS. THE TRANSCRANIAL DOPPLER SCAN SHOWED AN INCREASED SYSTOLIC VELOCITIES UPTO 300CM/S IN THE MIDDLE CEREBRAL ARTERY M1 SEGMENT. NO TREATMENT WAS PERFORMED AND AN ANGIOGRAM ONE YEAR LATER SHOWED THE LESION TO BE STABLE. THE MODIFIED RANKIN SCORE REMAINED UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT UNK484

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GATEWAY PTA BALLOON CATHETER (BOSTON SCIENTIFIC)