BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1840448 · Received September 21, 2010

    Report

    Report Number
    2134265-2010-04090
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE WITHDRAWAL RESISTANCE AND STENT DAMAGE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0X15MM VOYAGER BALLOON TO 10ATMS AND THEN THE 2.50X20MM TAXUS LIBERTE STENT WAS ADVANCED TO THE LESION. WHILE ADVANCING THE STENT DELIVERY SYSTEM (SDS), THE DEVICE GOT STUCK IN THE PROXIMAL RCA AND BECAME DEFORMED. THE PHYSICIAN WAS ABLE TO WITHDRAW THE DEVICE BY REMOVING EVERYTHING AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A 2.5X18MM NON BSC DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS 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 H7493893620250 12683281

    Patients

    Seq Age Sex Outcome Treatment
    1 MACH1 6FR GUIDE CATHETER| BMW GUIDEWIRE| 2.0X15MM VOYAGER BALLOON CATHETER