BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2061341 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01354
    Event Type
    Death
    Date Received
    April 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-01356. (B)(6) CLINICAL TRIAL IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED A 2.3X16MM, 80% STENOSED LESION OF THE R-PDA (RIGHT POSTERIOR DESCENDING ARTERY). TREATMENT CONSISTED OF PREDILATION AND PLACEMENT OF A 2.25X24MM TAXUS LIBERTE STUDY STENT RESULTING IN 0% RESIDUAL STENOSIS. A NON-TARGET LESION IN THE 2ND OM (OBTUSE MARGINAL) WAS ALSO TREATED. THE 99% STENOSED, 2.5X16MM LESION WAS TREATED WITH A 2.5X16MM TAXUS EXPRESS2 STENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2011, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DIAPHORESIS AND SUBSTERNAL CHEST PAIN. ECG SHOWED FIRST DEGREE HEART BLOCK WITH 3 TO 4MM ST ELEVATIONS IN LEADS 2, 3, AND AVF (AUGMENTED VOLTAGE FOOT). SHORTLY AFTER ARRIVAL THE PATIENT BECAME UNRESPONSIVE AND WAS INTUBATED. PULSELESS ACTIVITY SHOWED ON THE MONITOR EVOLVED INTO VENTRICULAR TACHYCARDIA. THE PATIENT WAS TREATED ACCORDING TO ADVANCED CARDIAC LIFE SUPPORT PROTOCOL, BUT A CODE WAS CALLED AND THE PATIENT EXPIRED. THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE WAS CARDIOPULMONARY ARREST WITH AN UNDERLYING CONDITION OF CORONARY ARTERY DISEASE. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death