BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1931018 · Received December 17, 2010

    Report

    Report Number
    2134265-2010-05486
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: 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 STENTING TREATMENT PROCEDURE, CROSSING DIFFICULTY AND STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY (LCX). THE LESION WAS PREDILATED AND A 2.75X24MM VERIFLEX MONORAIL STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A 2.75X16MM LIBERTE STENT. 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 - GALWAY H7493893424270 11995326

    Patients

    Seq Age Sex Outcome Treatment
    1