BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY STENT

    MDR report key: 1000408 · Received February 20, 2008

    Report

    Report Number
    2134265-2008-00486
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINANT 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), STENT DISLODGMENT OCCURRED. THE VERY CALCIFIED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PREDILATED THE LESION MULTIPLE TIMES, AND SUCCESSFULLY DELIVERED A 3.00X20MM STENT (TYPE UNK) AND A 3.00X24MM STENT (TYPE UNK). THE PHYSICIAN THEN ATTEMPTED TO DELIVER THE 3.00X28MM LIBERTE BARE (MR) STENT. THE PHYSICIAN PULLED BACK ON THE STENT AND THE STENT CAUGHT ON THE CALCIFICATION IN THE LESION AND DISLODGED FROM THE BALLOON. THE PHYSICIAN WAS ABLE TO RETRIEVE THE STENT AND THE CASE WAS COMPLETED WITHOUT PT COMPLICATIONS. THE PT CONDITION IS REPORTED AS FINE. FURTHER INFO WAS REQUESTED, BUT WAS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY STENT MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION NA 9433538

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention AL1 MEDTRONIC GUIDE CATHETER