BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1218946 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04190
    Event Type
    Death
    Date Received
    November 3, 2008
    Date of Event
    August 22, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS BECAUSE IT WAS IMPLANTED IN THE PATIENT. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED THAT 72 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT DIED. THE INDEX PROCEDURE TREATED THE 75% STENOSED, PROXIMAL RCA (RIGHT CORONARY ARTERY) WITH PREDILATION AND PLACEMENT OF A 3.0 X 28MM TAXUS EXPRESS2 DRUG ELUTING STENT. THE PATIENT WAS DISCHARGED TWO DAYS FOLLOWING THE PROCEDURE WITH NO REPORTED INJURIES OR COMPLICATIONS. THE INVESTIGATOR WAS LATER INFORMED THAT THE PATIENT EXPIRED FOLLOWING A CARDIO-RESPIRATORY ARREST AT ANOTHER HOSPITAL. THE INVESTIGATOR REPORTED THERE WAS POSSIBILITY THIS EVENT WAS RELATED TO THE DEVICE AND ANTIPLATELET MEDICATIONS (PANALDINE, BAYASPIRIN).

    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 CORPORATION 3.0X28MM 9570351

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death