BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1033549 · Received April 24, 2008

    Report

    Report Number
    2134265-2008-01186
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURED. A 3.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) HAD BEEN SELECTED TO TREAT AN UNSPECIFIED LESION. DURING UNPACKING, IT WAS NOTICED THAT A STENT STRUT APPEARED TO BE LIFTED. THE DEVICE WAS NOT USED IN THE PROCEDURE AND DID NOT CONTACT THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.5X24MM TAXUS EXPRESS2 DES. THERE WERE NO PT COMPLICATIONS REPORTED.

    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 3.5X24MM 11176312

    Patients

    Seq Age Sex Outcome Treatment
    1