BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 804699 · Received January 10, 2007

    Report

    Report Number
    6000089-2007-00052
    Event Type
    Injury
    Date Received
    January 10, 2007
    Date of Event
    March 2, 2006
    Report Date
    December 12, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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 # 6123105 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: IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PATIENT HAD A STENT THROMBOSIS (ST) AND TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS 3 MM WIDE, 20 MM LONG, AND 70% STENOSED. THERE WAS MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE PHYSICIAN DIRECT STENTED THE LESION WITH A 3.0 X 20 MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT RECEIVED PLAVIX DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED ONE DAY LATER ON ASPIRIN, PLAVIX AND PRAVACHOL. ON DAY 728, THE PATIENT HAD AN ST CONFIRMED BY ANGIOGRAPHY. A TVR WAS PERFORMED IN THE MID LAD, IN WHICH A TAXUS EXPRESS2 STENT WAS PLACED. THE EVENT WAS CONSIDERED RESOLVED THAT DAY, AND THE PATIENT WAS DISCHARGED ONE DAY LATER. IN THE OPINION OF THE PHYSICIAN, THERE IS NO RELATIONSHIP BETWEEN THE ST/TVR AND THE TAXUS STENT.

    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 3.0 X 20 MM 6123105

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R