BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 4101291 · Received September 19, 2014

    Report

    Report Number
    2134265-2014-06082
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. - THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS USER PREFERENCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT WAS INADVERTENTLY IMPLANTED. THE PHYSICIAN IMPLANTED A PROMUS PREMIER 2.75X12MM STENT IN THE CIRCUMFLEX ARTERY. THE PHYSICIAN REQUESTED A 3.0X8MM QUANTUM APEX BALLOON TO POST DILATE THE STENT. THE PHYSICIAN WAS INADVERTENTLY GIVEN A 3.0X8MM VERIFLEX STENT INSTEAD OF THE BALLOON. THE VERIFLEX STENT WAS DEPLOYED INSIDE THE PROMUS PREMIER STENT BEFORE IT WAS REALIZED THE PHYSICIAN WAS GIVEN A DEVICE DIFFERENT THAN WHAT WAS REQUESTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582631 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE UNK208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other