BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ¿

    MDR report key: 3022504 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01856
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 27, 2013
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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, STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE 75% STENOSED TARGET LESION LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY. A 4.0X32MM LIBERTE STENT WAS ADVANCED FOR TREATMENT BUT MET RESISTANCE THROUGH THE RIGHT SHOULDER AND WAS WITHDRAWN. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126321 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893832400 15610512

    Patients

    Seq Age Sex Outcome Treatment
    1