BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3021458 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01711
    Event Type
    Death
    Date Received
    March 26, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: BETWEEN APR 2002 TO MAR 2009. DEVICE IS A COMBINATION PRODUCT. CITATION; T. PILGRIM AND B. KALESAN ET AL. (2013) IMPACT OF ATRIAL FIBRILLATION ON CLINICAL OUTCOMES AMONG PATIENTS WITH CORONARY ARTERY DISEASE UNDERGOING REVASCULARISATION WITH DRUG-ELUTING STENTS. EUROINTERVENTION, 2013; 8: 1061-1071. IT IS 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 UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF A CLINICAL STUDY. THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE IMPACT OF ATRIAL FIBRILLATION (AF) ON LONG-TERM CLINICAL OUTCOMES IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH DRUG-ELUTING STENTS (DES). 6,308 CONSECUTIVE PATIENTS UNDERWENT PCI WITH AT LEAST ONE DES IMPLANT INCLUDING TAXUS EXPRESS2 STENT BETWEEN APRIL 2002 AND MARCH 2009, CLINICAL OUTCOMES INDICATES THE PATIENTS EXPERIENCED MULTIPLE ADVERSE EVENTS INCLUDING DEATH NOTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124476 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Death