BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1863988 · Received October 11, 2010

    Report

    Report Number
    2134265-2010-04422
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF A LIBERTE MR STENT DELIVERY SYSTEM (SDS). CONTRAST WAS VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS PREPPED FOR USE. THE DISTAL END OF THE SDS WAS INSPECTED UNDER MAGNIFICATION AND DAMAGE WAS FOUND ON THE STENT. IT WAS DETERMINED THAT THE STENT HAD MOVED ON BALLOON APPROXIMATELY 3MM DISTALLY FROM THE PROXIMAL MARKER BAND AND DAMAGE TO THE FIFTH AND SIXTH PROXIMAL ROWS WITH STRUTS BUNCHED UP. THE UNDAMAGED PORTION OF THE RETURNED STENT MEETS THE APPLICABLE SPECIFICATION FOR OUTER DIAMETER. 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 PATIENT HAD TWO LESIONS; ONE IN THE RIGHT CORONARY ARTERY AND ONE IN THE LEFT CIRCUMFLEX ARTERY. AS A 2.5X16MM LIBERTE' BARE METAL STENT WAS BEING PREPPED TO TREAT THE LESION IN THE LEFT CIRCUMFLEX ARTERY, STENT DAMAGE WAS NOTED. THE LESION WAS TREATED WITH ANOTHER 2.5X16MM LIBERTE' BARE METAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE PATIENT HAD TWO LESIONS; ONE IN THE RIGHT CORONARY ARTERY AND ONE IN THE LEFT CIRCUMFLEX ARTERY. AS A 2.5X16MM LIBERTE' BARE METAL STENT WAS BEING PREPPED TO TREAT THE LESION IN THE LEFT CIRCUMFLEX ARTERY, STENT DAMAGE WAS NOTED. THE LESION WAS TREATED WITH ANOTHER 2.5X16MM LIBERTE' BARE METAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816250 12971346

    Patients

    Seq Age Sex Outcome Treatment
    1