BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTÉ¿

    MDR report key: 3071106 · Received April 22, 2013

    Report

    Report Number
    2134265-2013-03102
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN SUCCESSFULLY DEPLOYED AND POST DILATED A 3.0X20MM LIBERTÉ STENT IN THE LESION. THEN THE PHYSICIAN ATTEMPTED TO ACCESS A SIDE BRANCH WITH A NON-BSC GUIDEWIRE AND THE GUIDEWIRE GOT STUCK IN THE IMPLANTED LIBERTÉ STENT CAUSING IT TO BECOME DEFORMED. THE ARTERY WAS OCCLUDED SO THE PHYSICIAN IMPLANTED A 3.X38MM NON-BSC STENT CRUSHING THE LIBERTÉ STENT AGAINST THE VESSEL WALL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171563 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893820300 15582433

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention BMW GUIDE WIRE