BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1243008 · Received November 21, 2008

    Report

    Report Number
    2134265-2008-04453
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 PROD 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

    SAME CASE AS: 2134265-2008-04454. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.50 X 20MM MAVERICK BALLOON. THE PHYSICIAN IMPLANTED THE 2.75X32MM TAXUS LIBERTE DRUG ELUTING STENT. AFTER IMPLANTING, DISSECTION WAS NOTED AT THE VESSEL NEAR THE STENT DISTAL EDGE. THE PHYSICIAN ATTEMPTED MANY TIMES TO PLACE A 2.50X8MM TAXUS LIBERTE DRUG ELUTING STENT TO COVER THE DISSECTION, BUT WAS UNABLE TO CROSS THE 2.75X32 MM TAXUS LIBERTE STENT. THE PHYSICIAN DILATED THE DISSECTION SITE USING AN UNK SIZE BALLOON. PT STATUS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.75X32 MM 11784254

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention