BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1151310 · Received September 4, 2008

    Report

    Report Number
    2134265-2008-02524
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    March 13, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 2134265-2008-02523. IT WAS REPORTED THAT 85 DAYS AFTER A CORONARY STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED CHEST PAIN. THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS 3.50MM, 90% STENOSED, 26MM LONG PORTION OF THE OSTIUM AND MID PORTION ON THE VESSEL IN AN UNK LOCATION. IT WAS A GRAFT LESION WITH IN-STENT RESTENOSIS. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF TWO (3.5X16MM AND 3.5X12MM) TAXUS EXPRESS2 STUDY STENTS IN AN OVERLAPPING FASHION IN THE TARGET LESION. POST DILATATION WAS NOT PERFORMED. THERE WERE NO COMPLICATIONS. POST STENOSIS WAS 0%. THE PT WAS DISCHARGED 9 DAYS LATER. AT 85 DAYS AFTER THE INDEX PROCEDURE, THE PT EXPERIENCED CHEST PAIN. AT 95 DAYS AFTER THE ONSET OF THE EVENT, THE PT'S STATUS REMAINS UNCHANGED. THE PT WILL HAVE CORONARY ANGIOGRAPHY (2008). THE RELATIONSHIP OF THE CHEST PAIN TO THE TAXUS STENT IS UNK.

    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 3.50X12MM 9764968

    Patients

    Seq Age Sex Outcome Treatment
    1 Other