BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY ST

    MDR report key: 762706 · Received September 18, 2006

    Report

    Report Number
    6000089-2006-02026
    Event Type
    Injury
    Date Received
    September 18, 2006
    Date of Event
    August 16, 2006
    Report Date
    August 21, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT # 6000098-2006-02025. CLINICAL TRIAL. IT WAS REPORTED THAT 171 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED IN-STENT RESTENOSIS (ISR). THE INDEX PROCEDURE IDENTIFIED ONE DE NOVO, 2.75X35MM, 80% STENOSED, MILDLY CALCIFIC, MILDLY TORTUOUS LESION IN THE 1ST RPL (RIGHT POSTEROLATERAL). THE LESION WAS PREDILATED USING A 2X20MM MAVERICK BALLOON AND TWO TAXUS LIBERTE DRUG ELUTING STENTS WERE DEPLOYED AT 20ATMS EACH. A 2.75X28MM IN THE DISTAL POSITION AND A 2.75X32MM IN THE PROXIMAL POSITION WERE USED RESULTING IN 0% RESIDUAL STENOSIS. THE PT WAS DISCHARGED THE FOLLOWING DAY ON ASA AND PLAVIX. THE PT UNDERWENT A TVR (TARGET VESSEL) REINTERVENTION) 171 DAYS FOLLOWING THE INDEX PROCEDURE DUE TO 100% DIFFUSE ISR. THE PT WAS REPORTED TO BE TAKING ASA AND PLAVIX AT THE TIME OF THIS EVENT. THE EVENT WAS REPORTED AS "DEFINITELY" RELATED TO THE STUDY DEVICE. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY ST DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.75X28MM 8120907

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R