BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT

    MDR report key: 1935919 · Received December 22, 2010

    Report

    Report Number
    2939204-2010-01164
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NEUROLOGICAL DEFICIT AND RESTENOSIS ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    COMPLAINT SOURCE - LITERATURE: AMIN-HANJANI ET AL. STROKE(USA)2010;41:2534-2538 - (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN STROKE JOURNAL THAT SIX MONTHS POST PROCEDURE THE PATIENT EXPERIENCED COGNITIVE DECLINE AND DECREASED FUNCTIONING. IMAGING REVEALED 84% IN-STENT STENOSIS OF THE PREVIOUSLY TREATED MIDDLE CAROTID ARTERY (MCA) AND A FLOW DECREASE OF MORE THAN 50% COMPARED WITH AN INITIAL POST-TREATMENT FLOW RATE. RE-ANGIOPLASTY WAS PERFORMED TO TREAT THE RECURRENT CRITICAL STENOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN STROKE JOURNAL THAT SIX MONTHS POST PROCEDURE THE PATIENT EXPERIENCED COGNITIVE DECLINE AND DECREASED FUNCTIONING. IMAGING REVEALED 84% IN-STENT STENOSIS OF THE PREVIOUSLY TREATED MIDDLE CAROTID ARTERY (MCA) AND A FLOW DECREASE OF MORE THAN 50% COMPARED WITH AN INITIAL POST-TREATMENT FLOW RATE. RE-ANGIOPLASTY WAS PERFORMED TO TREAT THE RECURRENT CRITICAL STENOSIS.

    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 45 YR Other| R