BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 795875 · Received December 12, 2006

    Report

    Report Number
    6000089-2006-02553
    Event Type
    Death
    Date Received
    December 12, 2006
    Date of Event
    December 7, 2005
    Report Date
    November 13, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: 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 MFG RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH #6935919 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL STUDY, SAME CASE AS MFR# 6000089-2006-02551, -02552. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT DIED. THE PT PRESENTED TO THE INDEX PROCEDURE WITH PROGRESSIVELY INCREASING ANGINA. TARGET LESION 1 WAS IDENTIFIED AS A GRAFTED PORTION OF THE 1ST OBTUSE MARGINAL (OM) WITH 95% STENOSIS, 3.5MM WIDE AND 50 MM LONG. THE LESION WAS TREATED WITH ANGIOPLASTY. THE PHYSICIAN PRE-DILATED THE LESION PRIOR TO PLACING A 3.5 X 24MM TAXUS EXPRESS2 STENT DISTALLY, A 3.5 X 24MM TAXUS EXPRESS2 STENT IN THE MID SEGMENT, AND A 3.5 X 12MM TAXUS EXPRESS2 STENT PROXIMALLY. ALL STENTS WERE OVERLAPPING. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATION. THE PT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. ON DAY 364, THE PT PRESENTED TO THE HOSPITAL IN CARDIOPULMONARY ARREST AND DID NOT RESPOND TO RESUSCITATIVE EFFORTS. IT WAS NOTED THAT THE PT HAD BEEN EXPERIENCING CHEST PAIN FOR A FEW DAYS PRIOR TO HIS PRESENTING CARDIAC ARREST. THE PT WAS PRONOUNCED DEAD. PER MEDICAL RECORD, THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST. NO AUTOPSY WAS PERFORMED AND NO DEATH CERTIFICATE IS AVAILABLE. IN THE OPINION OF THE PHYSICIAN, THERE IS AN UNK RELATIONSHIP BETWEEN THE DEATH AND THE TAXUS STENTS. THE PT WAS SEEN AT THE TRIAL SITE IN 2005. THE PT EXPIRED AFTER THIS FOLLOW UP APPOINTMENT AND WAS NOT DUE FOR ANOTHER FOLLOW UP UNTIL NOVEMBER 2006. HENCE, THE SITE WAS NOT AWARE UNTIL NOVEMBER 2006 THAT THE PT HAD EXPIRED.

    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 CORP. 3.5 X 24MM 6935919

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death