BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1662824 · Received April 20, 2010

    Report

    Report Number
    2134265-2010-01692
    Event Type
    Death
    Date Received
    April 20, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - AS A UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND AND MET ALL SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, SUBACUTE THROMBOSIS AND DEATH OCCURRED. APPROXIMATELY TWO WEEKS PRIOR TO THE PROCEDURE, THE PATIENT HAD A MYOCARDIAL INFARCTION. TWO LESIONS WERE IDENTIFIED; A 100% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) AND A 90% STENOSED ECCENTRIC DE NOVO LESION IN A MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE VESSELS WERE PREDILATED AND A 3.0X32MM TAXUS LIBERTE¿ DRUG ELUTING STENT WAS PLACED IN THE LAD AND A 2.75X38MM TAXUS LIBERTE¿ DRUG ELUTING STENT WAS PLACED IN THE RCA. A THIRD 2.75X23MM NON BSC STENT WAS PLACED IN THE DISTAL THIRD RCA. THE 10,000 UNITS OF HEPARIN AND GP IIB/IIIA WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN REPORTED AN ¿EXCELLENT¿ RESULT. NO PATIENT INJURIES OR COMPLICATIONS OCCURRED. PATIENT STATUS WAS SATISFACTORY. FOUR DAYS LATER THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. ANGIOGRAPHY SHOWED THE STENT IN THE LAD WAS TOTALLY OCCLUDED WITH THROMBUS. THE STENTS IN THE RCA WERE PATENT. A THROMBECTOMY CATHETER WAS USED IN AN ATTEMPT TO RESTORE FLOW TO THE LAD. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA FOLLOWED BY VENTRICULAR FIBRILLATION AND WAS ASYSTOLE. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND INTRACORONARY STREPTOKINASE WAS ADMINISTERED. THE PHYSICIAN WAS UNABLE TO RESTORE FLOW TO THE LAD AND THE PATIENT EXPIRED IN THE CATH LAB.

    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 H7493894032300 0012902272

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death 2.75X23MM EUROCOR STENT| 2.75X38MM TAXUS LIBERTE' STENT