BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX?

    MDR report key: 3935924 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04189
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 DISLODGEMENT OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE CALCIFIED AND TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA), THE PHYSICIAN ATTEMPTED TO DEPLOY A 4.00MM X 24MM VERIFLEX¿ STENT. HOWEVER, THE STENT DISLODGED FROM THE DEVICE AND REMAINED IN THE PATIENT IN THE PROXIMAL RCA. THE PHYSICIAN WENT BACK IN WITH ANOTHER DEVICE AND WAS ABLE TO PRESS THE STENT TO THE SIDE AND REGAIN FLOW TO THE VESSEL. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414397 VERIFLEX? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893424400 16234714

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention