BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1911093 · Received November 30, 2010

    Report

    Report Number
    2134265-2010-05331
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    April 14, 2009
    Report Date
    November 2, 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: 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 REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. A TYPE B2, BIFURCATED LONG LESION WAS IDENTIFIED IN THE CALCIFIED AND TORTUOUS MID RIGHT CORONARY ARTERY (RCA). TREATMENT CONSISTED OF PRE-DILATION AND THE PLACEMENT OF A 3.5X20MM TAXUS LIBERTE STENT DEPLOYED AT 12 ATMS. POST STENT IVUS CONFIRMED THE STENT WAS WELL APPOSED WITH 0% RESIDUAL STENOSIS. AFTER THE STENT WAS IMPLANTED, THE PATIENT EXPERIENCED SLOW FLOW. IT WAS NOTED THAT DUE TO CALCIFICATION IN THE VESSEL, THE 3.5X20MM TAXUS LIBERTE STENT MAY NOT HAVE DILATED PROPERLY. AN ADDITIONAL 3.5X20MM TAXUS LIBERTE STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT'S MEDICINE REGIMEN INCLUDED PANALDINE. ON DAY 5, WHILE THE PATIENT WAS STILL IN THE HOSPITAL, THE PATIENT EXPERIENCED AN ACUTE MYOCARDIAL INFARCTION. ANGIOGRAPHY WAS PERFORMED REVEALING STENT THROMBOSIS IN THE 3.5X20MM TAXUS LIBERTE IMPLANTED IN THE MID RCA. AN INTRA-AORTIC BALLOON PUMP WAS INSERTED AND A THROMBECTOMY USING A NON BSC DEVICE WAS PERFORMED RESULTING IN TIMI 3 FLOW. THE PATIENT'S STATUS BECAME STABLE. THE PATIENT WAS DISCHARGED IN (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 3.5X20MM TAXUS LIBERTE STENT WAS PROPERLY DILATED. THE VESSEL CALCIFICATION MADE IT DIFFICULT TO DILATE THE VESSEL.

    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 H7493893620350

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R