BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001190 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00497
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE: (B)(6) 2006. DEVICE EVALUATED BY MFR. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-00498. IT WAS REPORTED BY THE PATIENT THAT THE PATIENT UNDERWENT A REINTERVENTION. THE PATIENT STATES SHE HAD TWO TAXUS EXPRESS2 STENTS PLACED IN (B)(6) 2006. IN (B)(6) 2009, THE PATIENT REPORTS THAT A THIRD PROMUS STENT WAS PLACED TO "REDO" THE PREVIOUSLY PLACED STENTS. THE PATIENT ALSO REPORTS FEELING CHEST PRESSURE AND TIGHTNESS IN THE MIDDLE OF HER UPPER CHEST. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897016300 0008637660

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention