BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2243560 · Received September 12, 2011

    Report

    Report Number
    2134265-2011-03898
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    November 16, 2010
    Report Date
    August 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT'S QUALIFYING CONDITION WAS CCS CLASS II STABLE ANGINA. CARDIAC CATHETERIZATION REVEALED 75% IN STENT RESTENOSIS (56% VIA CORE LAB ANALYSIS) THAT WAS 16MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM AND TIMI-3 FLOW. THE LESION WAS TREATED WITH PREDILATION AND DEPLOYMENT OF A 3.5X16MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE PATIENT WAS DISCHARGED 4 DAYS LATER ON ASPIRIN AND TICLOPIDINE HYDROCHLORIDE. AT THE TIME OF THE EVENT, CARDIAC CATHETERIZATION REVEALED THE TARGET LESION LENGTH WAS 10MM WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. IT WAS PREVIOUSLY REPORTED TO BE 10.1MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.93MM. IT WAS VISUALLY 75% STENOSED (70% VIA CORE LAB ANALYSIS) AND FOLLOWING TREATMENT, THERE WAS VISUALLY 25% RESIDUAL STENOSIS (30% VIA CORE LAB ANALYSIS).

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS MFR ID#: 2134265-2011-03882. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. ON AN UNKNOWN DATE, AN UNKNOWN SIZE TAXUS LIBERTE STENT WAS IMPLANTED TO TREAT A TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. (B)(6) 2010: CARDIAC CATHETERIZATION REVEALED RESTENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY. THERE WERE NO ISCHEMIC SYMPTOMS. THE LESION WAS 70% STENOSED, 10.1MM LONG WITH A TARGET VESSEL DIAMETER OF 3.93MM AND MINIMUM LUMEN DIAMETER OF 1.17MM AND TIMI-3 FLOW. THIS WAS TREATED WITH ANGIOPLASTY RESULTING IN 30% RESIDUAL STENOSIS, TARGET VESSEL DIAMETER OF 3.78MM, MINIMUM LUMEN DIAMETER OF 2.61MM AND TIMI-3 FLOW. THE PATIENT'S CONDITION IMPROVED AND WAS DISCHARGED 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R