BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1944325 · Received January 3, 2011

    Report

    Report Number
    2134265-2010-05661
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 6, 2010
    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 MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2010-05824. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED. THE 90% STENOSED, 3.0X50MM DENOVO TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0X12MM MAVERICK2 BALLOON. A 3.5X32MM TAXUS LIBERTE STENT WAS DEPLOYED IN THE LESION AT 14ATMS AND THEN A 3.5X28MM TAXUS LIBERTE STENT WAS DEPLOYED AT 15ATMS IN THE PROXIMAL RCA, OVERLAPPING THE FIRST PLACED STENT. IT WAS NOTED THAT THE SINUS NODE BRANCH BECAME OCCLUDED, CAUSING SINUS BRADYCARDIA. ATROPINE WAS ADMINISTERED AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PATIENT COMPLICATIONS AND THE PATIENT WAS PUT ON TICLOPIDINE AND ASPIRIN. INTERVENTION FOR THE 100% STENOSED OBTUSE MARGINAL (OM) AND 75% STENOSED LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS SCHEDULED FOR ANOTHER DAY. AN UNSPECIFIED NUMBER OF HOURS LATER, THE PATIENT COMPLAINED OF CHEST PAIN AND THE PATIENT'S BLOOD PRESSURE DECREASED. THROMBOSIS WAS CONFIRMED IN THE TWO PREVIOUSLY IMPLANTED TAXUS LIBERTE STENTS. ROTATIONAL ATHERECTOMY WAS PERFORMED ALONG WITH BALLOON ANGIOPLASTY TO SUCCESSFULLY TREAT THE THROMBOSIS, RESTORING TIMI 3 FLOW. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED THREE DAYS LATER IN GOOD CONDITION.

    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 71 YR Required Intervention 3.5X28MM TAXUS LIBERTE STENT