BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 763117 · Received September 18, 2006

    Report

    Report Number
    6000089-2006-02037
    Event Type
    Injury
    Date Received
    September 18, 2006
    Date of Event
    June 25, 2006
    Report Date
    August 24, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    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 DEICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MFG RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATH # 8172883 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 TRIAL. IT WAS REPORTED THAT 144 DAYS POST INDEX PROCEDURE, THE PT EXPERIENCED A MYOCARDIAL INFARCTION (MI), A STENT THROMBOSIS (ST) AND SUBSEQUENT TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED A DE NOVO BIFURCATED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS 3.5 MM WIDE, 28 MM LONG AND 75% STENOSED. THERE WAS MILD TORTUOSITY. THE PHYSICIAN DIRECT STENTED THE LESION WITH A 3.0 X 32 MM TAXUS LIBERTE STENT. POST DILATATION STENOSIS WAS 0%. THE PT WAS DISCHARGED 6 DAYS POST INDEX PROCEDURE RECEIVING ASPIRIN AND PLAVIX. ON DAY 144, THE PT EXPERIENCED A Q-WAVE MI. ECG AND ENZYMES WERE CONSISTENT WITH MI. THE PT UNDERWENT ANGIOGRAPHY, WHICH REVELED THE ST IN THE PROX LAD. THE PT HAD BALLOON ANGIOPLASTY TO THE PROX RCA, REDUCING THE STENOSIS FROM 100% TO 0%. THE EVENT WAS CONSIDERED RESOLVED AFTER TVR. AS OF NOTE, THE PT HAD STOPPED TAKING PLAVIX 24 DAYS BEFORE THE EVENTS OCCURRED. IN THE OPINION OF THE PHYSICIAN, THERE IS A POSSIBLE RELATIONSHIP BETWEEN THE MI/ST/TVR AND THE LIBERTE STENTS. THIS PRODUCT IS ONLY OUS APPROVED, BUT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0 X 32 MM 8172883

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R