BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1654134 · Received April 8, 2010

    Report

    Report Number
    2134265-2010-01901
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    August 29, 2009
    Report Date
    March 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AS THE DEVICE HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. 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

    (B) (4). SAME CASE AS 2134265-2010-01923. IT WAS REPORTED THAT AFTER A CORONARY ARTERY STENTING PROCEDURE, THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (MID LAD) ARTERY, WITH 88% STENOSIS AND WAS 18.6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.01 MM. THE LESION WAS TREATED WITH PRE-DILATATION, AND IMPLANTING A 3.0 X 24MM TAXUS LIBERTE STUDY STENT AND POST-DILATATION WITH 10% RESIDUAL STENOSIS. A NON-TARGET LESION IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) WAS TREATED WITH A TAXUS EXPRESS STENT DURING THE INDEX PROCEDURE. THE PATIENT WAS DISCHARGED ON 2 DAYS LATER ON ASPIRIN AND CLOPIDOGREL. IN (B) (6) 2009, THE PATIENT DEVELOPED BRADYCARDIA WITH PULSELESS ELECTRICAL ACTIVITY. WITH CPR, THE PATIENT WAS CONVERTED TO SINUS RHYTHM AND WAS INTUBATED. THE PATIENT WAS ADMITTED AND HAD PROGRESSIVELY WORSENING LIVER FUNCTION TESTS, DEVELOPED HEPATORENAL SYNDROME, ACUTE RENAL INJURY WITH ANURIA, AND WORSENING RENAL IMPAIRMENT. THE PATIENT WAS CONTINUED ON SUPPORTIVE CARE WITH CONTINUOUS DIALYSIS WITH SUBSEQUENT RETURN OF RENAL FUNCTION. PATIENT WAS WEANED OFF DIALYSIS BUT THEN DEVELOPED RENAL IMPAIRMENT SECONDARY TO DEHYDRATION AND HEPATORENAL SYNDROME. THE PATIENT WAS REFERRED TO GASTROENTEROLOGY REGARDING LIVER FAILURE. IT WAS BELIEVED TO BE CAUSED BY ISCHEMIC HEPATITIS AND THE PROGNOSIS WAS POOR. THE PATIENT WAS EXTUBATED AFTER BECOMING PROGRESSIVELY MORE ALERT AND MEDICAL THERAPY CONTINUED. AT 1742 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT BEGAN TO DETERIORATE WITH INCREASED SHORTNESS OF BREATH AND WORSENING KIDNEY FUNCTION. THE PATIENT WAS NOTED TO BE BRADYCARDIC. CPR WAS STARTED BUT THE PROGNOSIS WAS POOR AND THE PATIENT WAS MADE DNR. AT 2 DAYS LATER, THE PATIENT DIED. CAUSE OF DEATH PER MORTALITY REPORT FORM WAS MULTIPLE ORGAN FAILURE WITH ¿DIVC¿ SHOCK. NO AUTOPSY WAS PERFORMED.

    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 H7493893624300 6961413

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death