BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1894216 · Received November 9, 2010

    Report

    Report Number
    2134265-2010-05065
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE LESION LOCATION AND LESION CHARACTERISTICS ARE UNKNOWN. THE PHYSICIAN ADVANCED THE 16MM X 3.50MM VERIFLEX CORONARY STENT DELIVERY SYSTEM UP TO THE LESION. AS THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH THIS DEVICE, IT WAS NOTED THAT "IT WAS DIFFICULT TO CROSS". THE PHYSICIAN CONTINUED TO ATTEMPT TO CROSS THE LESION FOR APPROXIMATELY FIVE MINUTES, BUT WAS UNSUCCESSFUL. THE VERIFLEX WAS REMOVED AND IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS FLARED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 H7493893416350 11207777

    Patients

    Seq Age Sex Outcome Treatment
    1