BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1823813 · Received September 2, 2010

    Report

    Report Number
    2134265-2010-03810
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF A MONORAIL (MR) LIBERTE/VERIFLEX STENT DELIVERY SYSTEM. A BLOOD-LIKE SUBSTANCE WAS VISIBLE WITHIN THE GUIDEWIRE LUMEN. MICROSCOPIC EXAMINATION OF THE DISTAL COMPONENTS REVEALED THAT THE STENT MOVED APPROXIMATELY 4 MM DISTALLY. THE STENT WAS ALSO DAMAGED IN THE FIFTH PROXIMAL ROW. SEVERAL ROWS OF THE STENT WERE BUNCHED TOGETHER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.0X24MM VERIFLEX STENT WAS PREPPED IN THE NORMAL FASHION. AS THE DEVICE BEING LOADED ONTO THE WIRE, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER VERIFLEX STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT CONDITION IS LISTED AS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.0X24MM VERIFLEX STENT WAS PREPPED IN THE NORMAL FASHION. AS THE DEVICE BEING LOADED ONTO THE WIRE, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER VERIFLEX STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT CONDITION IS LISTED AS 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 H7493893424300 11435878

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR