BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX?

    MDR report key: 3924811 · Received July 10, 2014

    Report

    Report Number
    2134265-2014-03905
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY. A 3.50MM X 8MM VERIFLEX¿ STENT WAS SELECTED TO TREAT THE TARGET LESION; HOWEVER THE DEVICE WAS UNABLE TO CROSS THE LESION. IT WAS SUSPECTED THAT THE PROXIMAL END OF THE STENT MIGHT HAVE BEEN FRAYED. THE PHYSICIAN WAS UNABLE TO PLACE A STENT AND COMPLETED THE PROCEDURE WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403756 VERIFLEX? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H749389348350 16584163

    Patients

    Seq Age Sex Outcome Treatment
    1