BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1241077 · Received November 20, 2008

    Report

    Report Number
    2134265-2008-04401
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL, 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 CORONARY STENTING TREATMENT PROCEDURE, A STENT EMBOLIZATION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 3.0X12MM NON-BSC BALLOON. THE PHYSICIAN HAD DIFFICULTY PLACING THE 3.50X24MM LIBERTE BARE METAL STENT, SO HE BUDDY WIRED IT. THEN HE DECIDED TO REMOVE THE BUDDY WIRE AND IN DOING SO, THE GUIDE CATHETER WENT FORWARD DISLODGING THE STENT FROM THE STENT DELIVERY BALLOON (SDS) IN THE RCA. THE PHYSICIAN USED A 2.5X20MM NON-BSC BALLOON TO GUIDE AND DEPLOY THE STENT TO THE ORIGINAL LESION LOCATION. THEN HE DEPLOYED A 3.50X12MM LIBERTE BARE METAL STENT, INFLATED TWICE TO 18ATM FOR 30 SECONDS TO COMPLETELY COVER UP THE LESION. THE STENTS WERE POST DILATED WITH A 3.50X15MM NON-BSC BALLOON, INFLATED 3 TIMES 14-20 ATM FOR 20-30 SECONDS. MEDICATION: HEPARIN, NITROGLYCERIN, AND REOPRO. PT STATUS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 11759139

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DURASTAR BALLOON| VOYAGER BALLOON