BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 792181 · Received December 6, 2006

    Report

    Report Number
    6000089-2006-02526
    Event Type
    Death
    Date Received
    December 6, 2006
    Date of Event
    November 11, 2006
    Report Date
    November 13, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6. A UNIT HAS NOT BEEN RETURNED FOR REVIEW; THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MFG RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8893660 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE OF THE COMPLAINT INCIDENT COULD NOT BE DETERMINED. THERE ARE FOUR SIMILAR COMPLAINTS, OF THIS NATURE, RELATED TO THIS BATCH #.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS AND DEATH OCCURRED. THE PHYSICIAN PLACED A TAXUS EXPRESS2 2.5X24MM DRUG ELUTING STENT TO THE 70% STENOSED LESION LOCATED IN THE NONTORTUOUS, NONCALCIFIED, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A 20MM BALLOON, UNK TYPE. THE LESION POST-DILATED WITH A 20MM BALLOON. "THE PT DIED AFTER THE STENT WAS IMPLANTED." ADD'L INFO REGARDING THIS EVENT HAS BEEN REQUESTED.

    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 2.5X24MM 8893660

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death