BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2110552 · Received June 1, 2011

    Report

    Report Number
    2134265-2011-01927
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-01926. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A VESSEL DISSECTION OCCURRED. THE APPROXIMATELY 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND NON-TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA). A 4.50X12MM VERIFLEX STENT WAS ADVANCED AND DEPLOYED WITHOUT ISSUES. A 5.00X8MM NC QUANTUM APEX BALLOON CATHETER WAS THEN USED TO POST-DILATE. DURING THE FIRST INFLATION, THE PHYSICIAN MADE A COMMENT THAT "THE SHOULDERS WERE VERY LARGE ON THE BALLOON". UPON THIS INFLATION, A VESSEL DISSECTION OCCURRED IN THE DISTAL END OF THE VERIFLEX STENT. ANOTHER BALLOON CATHETER WAS INTRODUCED FOR DILATION AND THEN ANOTHER VERIFLEX STENT WAS IMPLANTED OVERLAPPING THE DISTAL END OF THE PREVIOUSLY IMPLANTED VERIFLEX STENT TREATING THE DISSECTION. THE PATIENT REMAINED STABLE THROUGHOUT. THE PROCEDURE WAS CONSIDERED COMPLETED AT THIS POINT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893412450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NC QUANTUM APEX MR 8MM X 5.00MM