BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTÉ (TM)

    MDR report key: 2243527 · Received September 12, 2011

    Report

    Report Number
    2134265-2011-03896
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    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

    SAME CASE AS MFR ID#: 2134265-2011-03899. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, INSUFFICIENT APPOSITION AND A BALLOON RUPTURE OCCURRED. THE UNKNOWN TARGET LESION WAS TREATED WITH PREDILATION AND DEPLOYMENT OF A 3.0X24MM LIBERTE BARE STENT. DUE TO TAPERING IN THE DISTAL PORTION OF THE VESSEL, IT WAS REPORTED THAT THE STENT "DID NOT EXPAND ENOUGH" AND DID NOT UNIFORMLY EXPAND WHEN DEPLOYED, REQUIRING ADDITIONAL BALLOON DILATIONS. A 3.25X15MM NC QUANTUM APEX WAS ADVANCED AND RUPTURED UPON ITS FIRST INFLATION AT 16ATM. THE DEVICE WAS REMOVED INTACT AND WAS COMPLETED WITH A 3.5X15MM NC QUANTUM BALLOON. THERE WERE NO ISSUES AFTER POST DILATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTÉ (TM) STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893824300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention