BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1962583 · Received January 18, 2011

    Report

    Report Number
    2134265-2010-05918
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION TO REPORT, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. A TAXUS STENT WAS DEPLOYED IN THE DISTAL LEFT CIRCUMFLEX (LCX). THE STENT WAS POST DILATED AND WAS WELL POSITIONED AND WELL APPOSED. APPROXIMATELY 9 MONTHS LATER, THE PATIENT PRESENTED WITH CHEST PAIN. ONE WEEK LATER THE PATIENT WAS BROUGHT BACK FOR A SCHEDULED PERCUTANEOUS CORONARY INTERVENTION (PCI). IN STENT RESTENOSIS WAS NOTED IN THE PREVIOUSLY PLACED TAXUS STENT. A 10/2.5MM FLEXTOME CUTTING BALLOON WAS ADVANCED BUT COULD NOT CROSS THE LESION. NEXT, A 1.5MM NON-BSC DEVICE CROSSED THE LESION AND WAS INFLATED TO 8ATMS. THE PROCEDURE WAS COMPLETED WITH A 2.5X12MM NC QUANTUM APEX BALLOON. THE RESTENOSIS WAS SUCCESSFULLY TREATED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention