BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 767845 · Received October 5, 2006

    Report

    Report Number
    6000089-2006-02195
    Event Type
    Death
    Date Received
    October 5, 2006
    Date of Event
    August 17, 2006
    Report Date
    September 5, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW THEREFORE A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8213781 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS MFR# 6000089-2006-02194, -02193, -02195, 6000093-2006-02008, -02007, -02006. IT WAS REPORTED THAT 17 DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 6 TARGET LESIONS. TARGET LESION 1 RECEIVED A 2.75 X 32 MM TAXUS EXPRESS2 STENT TO THE MID RIGHT CORONARY ARTERY (RCA). TARGET LESION 2 WAS IN THE PROXIMAL RCA AND RECEIVED A 3.0 X 32 MM TAXUS EXPRESS2 STENT. THE 2 STENTS IN THE RCA OVERLAPPED. TARGET LESION 3 WAS IN THE OBTUSE MARGINAL AND RECEIVED A 2.5 X 12 MM TAXUS EXPRESS2 STENT. TARGET LESION 4 WAS IN THE DISTAL CIRCUMFLEX (CX), WHICH RECEIVED A 2.5 X 24 MM TAXUS EXPRESS2 STENT. TARGET LESION 5 WAS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND RECEIVED A 2.5 X 16 MM TAXUS EXPRESS2 STENT. LASTLT, TARGET LESION 6 IN THE 1ST DIAGONAL RECEIVED A 2.25 X 24 MM TAXUS EXPRESS2 STENT. NONE OF THE LESIONS WERE TORTUOUS OR HEAVILY CALCIFIED. THE PATIENT RECEVIED HEPARIN AND NITRATES DURING THE PROCEDURE. RESIDUAL STENOSIS WAS LESS THAN 30% POST INDEX PROCEDURE IN ALL LESIONS. TWO HOURS POST INDEX PROCEDURE, THE PATIENT HAD A TOTAL OCCLUSION DUE TO STENT THROMBOSIS IN THE LAD. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MYOCARDIAL INFRACTION AS WELL. THE PATIENT HAD AN EMERGENT VESSEL REVASCULARIZATION AND RECEIVED 2 NON STUDY TAXUS STENTS TO THE PROXIMAL LAD AND 1ST DIAGONAL. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT HAD WORSENING LEFT VENTRICULAR DYSFUNCTION, CATHETER SITE BLEEDING AND MITRAL VALVE REGURGITATION. THE PATIENT DEVELOPED CARDIOGENIC SHOCK 3 DAYS LATER, DUE TO EXTENSION OF MI. AN INTRA AORTIC BALLOON PUMP WAS PLACED AND THE PATIENT WAS INTUBATED. THE PATIENT THEN DEVELOPED A FEVER OF UNK ORIGIN, ANEMIA AND VENTRICULAR BIGEMINY. ATRIAL FIBRILLATION AND MULTIPLE EPISODES VENTRICULAR TACHYCARDIAC/VENTRICULAR FIBRILLATION ALSO OCCURRED. TWO DAYS PRIOR TO DEATH, THE PATIENT HAD A MITRAL VALVE REPLACED, WHICH WAS COMPLICATED BY NEED FOR BILATERAL VENTRICUALR ASSIST DEVICE. SUPPROT WAS WITHDRAWN DUE TO POOR PROGNOSIS AND THE PATIENT EXPIRED THAT DAY (17 DAYS POST INDEX PROCEDURE). IN THE OPINION OF THE PHYSICIAN, THE ST/MI AND DEATH HAD A HIGHLY PROBABLE RELATIONSHIP TO THE STUDY DEVICE.

    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. 2.5 X 12 MM 8213781

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death