BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 695195 · Received March 31, 2006

    Report

    Report Number
    6000093-2006-00556
    Event Type
    Death
    Date Received
    March 31, 2006
    Date of Event
    February 21, 2006
    Report Date
    March 2, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY - IT WAS REPORTED THAT 25 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PATIENT PRESENTED WITH A SUBACUTE THROMBOSIS AND EXPIRED OIN AN UNKNOWN DATE. PATIENT WAS ON HEPARIN, NO INFORMATION ON OTHER MEDICATIONS. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 2.72X28MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death