BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1760802 · Received July 19, 2010

    Report

    Report Number
    2134265-2010-03068
    Event Type
    Death
    Date Received
    July 19, 2010
    Report Date
    June 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEATH DATE - (B) (6) 2010.EVENT DATE - (B) (6) 2010.IF IMPLANTED, GIVE DATE - (B) (6) 2010.DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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 POST STENTING TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. A TAXUS LIBERTE' DRUG ELUTING STENT WAS PLACED IN AN UNSPECIFIED CORONARY ARTERY. TWO DAYS LATER THE PATIENT PRESENTED WITH CHEST PAIN AND ST ELEVATIONS. THE PATIENT WAS SENT TO THE CATH LAB AND THE STENT APPEARED PATENT. TWO DAYS LATER, THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    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 - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death