BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT

    MDR report key: 1912876 · Received December 2, 2010

    Report

    Report Number
    2939204-2010-01135
    Event Type
    Injury
    Date Received
    December 2, 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

    LITERATURE: COSTALAT ET AL, NEUROSURGERY 2010: 67(6); 1505-15 - (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT A PATIENT HAD KNOWN MILD RESIDUAL C3 STENOSIS AND AN IN-STENT RESTENOSIS WAS SUSPECTED AT SIX MONTH FOLLOW UP BUT THE PATIENT REFUSED ANGIOGRAPHIC FOLLOW UP AND WAS AYMPTOMATIC. NO TREATMENT WAS GIVEN AND THERE WAS NO CHANGE IN MRS SCORE OF NEUROLOGICAL STATUS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT A PATIENT HAD KNOWN MILD RESIDUAL C3 STENOSIS AND AN IN-STENT RESTENOSIS WAS SUSPECTED AT SIX MONTH FOLLOW UP BUT THE PATIENT REFUSED ANGIOGRAPHIC FOLLOW UP AND WAS AYMPTOMATIC. NO TREATMENT WAS GIVEN AND THERE WAS NO CHANGE IN MRS SCORE OF NEUROLOGICAL STATUS.

    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)