BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1052505 · Received May 22, 2008

    Report

    Report Number
    2134265-2008-01485
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. AS THE TAXUS EXPRESS2 2.5X16MM DRUG ELUTING STENT WAS INSERTED, THE HYPOTUBE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS EXPRESS2 STENT. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    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 2.5X16MM 11288799

    Patients

    Seq Age Sex Outcome Treatment
    1