BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT

    MDR report key: 755202 · Received August 24, 2006

    Report

    Report Number
    6000093-2006-01628
    Event Type
    Death
    Date Received
    August 24, 2006
    Date of Event
    December 21, 2005
    Report Date
    July 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 236 DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 1 DE NOVO LESION IN THE PROXIMAL RCA. NO LESION CHARACTERISTICS ARE AVAILABLE. THE PHYSICIAN PRE-DILATED THE LESION PRIOR TO PLACING A 2.75 X 28 MM TAXUS EXPRESS2 STENT, ALONG WITH A 2.5 X 20MM TAXUS EXPRESS2 STENT. THE 2 STENTS OVERLAPPED. THE PATIENT RECEIVED HEPARIN AND PLAVIX DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED 2 DAYS POST INDEX PROCEDURE RECEIVING ASPIRIN AND PLAVIX. ON DAY 236, THE PATIENT EXPIRED. THE SITE REPORTED THE DEATH AS CARDIAC RELATED. THE PATIENT WAS TAKING ASPIRIN AND PLAVIX AT THE TIME OF THE EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.75 X 28 MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death