BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1469913 · Received September 10, 2009

    Report

    Report Number
    2134265-2009-04644
    Event Type
    Death
    Date Received
    September 10, 2009
    Date of Event
    February 1, 2006
    Report Date
    August 11, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH # IS UNK AND THE MFG RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. LITERATURE CITATION: YA-LING H, XIAO-ZENG W, QUAN-MIN J, SHOU-LI W ET AL. COMPARISON OF RAPAMYCIN AND PACLITAXEL ELUTING STENT IN PTS WITH MULTI-VESSEL CORONARY DISEASE. CHINESE JOURNAL OF CARDIOLOGY 2006; 34: 123-130.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE TITLED: COMPARISON OF RAPAMYCIN AND PACLITAXEL ELUTING STENT IN PTS WITH MULTI-VESSEL CORONARY DISEASE, (ATTACHED) THAT POST CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE DEATH FROM HEART FAILURE OCCURRED. DURING THE INITIAL PROCEDURE AN UNSPECIFIED TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT WAS IMPLANTED. TARGET LESION LOCATION AND LESION CHARACTERISTICS WERE NOT PROVIDED. AT SOME POINT POST-PROCEDURE DEATH FROM HEART FAILURE OCCURRED. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death