BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2032628 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01014
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RE-STENOSIS OCCURRED. THE 90% RESTENOSED 3.0X12MM TAXUS LIBERTE' WAS LOCATED IN A MODERATELY TORTUOUS AND NON CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.5 X 10MM FLEXTOME MONORAIL CUTTING BALLOON WAS USED TO RE-DILATE, BUT THIS RUPTURED. PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RE-STENOSIS OCCURRED. THE 90% RESTENOSED 3.0X12MM TAXUS LIBERTE' WAS LOCATED IN A MODERATELY TORTUOUS AND NON CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.5 X 10MM FLEXTOME MONORAIL CUTTING BALLOON WAS USED TO RE-DILATE, BUT THIS RUPTURED. PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893812300 13349460

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 3.5 X 10MM FLEXTOME MR CUTTING BALLOON.