BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1241066 · Received November 20, 2008

    Report

    Report Number
    2134265-2008-04419
    Event Type
    Injury
    Date Received
    November 20, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025/S21
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNK, THEREFORE, A REVIEW OF THE MFG DOCUMENTATION COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, AN OCCLUSION OCCURRED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 ATOM DRUG ELUTING STENT, UNK SIZE, TO AN UNK VESSEL. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. FOUR DAYS POST PROCEDURE, THE PT'S "ARTERY WAS BLOCKED AGAIN". THE LESION WAS DILATED, UNK TYPE AND SIZE BALLOON, AND THE PT WAS STABLE POST PROCEDURE. ADD'L INFO REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1