BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1709256 · Received June 3, 2010

    Report

    Report Number
    2134265-2010-02561
    Event Type
    Death
    Date Received
    June 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    May 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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) CLINICAL STUDY. SAME CASE AS 2134265-2010-02395. SAME PATIENT AS 2134265-2009-06869 AND 2134265-2009-06870. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING PROCEDURE, THE PATIENT EXPIRED. THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PROX LAD) ARTERY. THE PHYSICIAN TREATED THE LESION BY IMPLANTING TWO (3.00X24MM & 2.50X24MM) TAXUS EXPRESS2 STUDY STENTS. IN (B) (6) 2010, THE PATIENT DIED AT HOME AND HAD BEEN TRANSFERRED TO ANOTHER FACILITY. THEY WERE UNABLE TO OBTAIN DETAILED INFORMATION REGARDING THE DEATH.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LESION WAS A DE NOVO LESION WITH REFERENCE VESSEL DIAMETER OF 3.00MM, LENGTH OF 45.0MM, AND VISUALLY 100% STENOSIS AND WAS TREATED WITH PRE-DILATATION AND THE OVERLAPPING STENTS WITHOUT GAP, AND POST-DILATION. RESIDUAL STENOSIS BECAME VISUALLY 0% AND TIMI FLOW IMPROVED FROM 0 TO 3 THROUGH THE INDEX PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS 2 DAYS LATER ON BAYASPIRIN AND PANALDINE. THE DISEASE TRAJECTORY BEFORE THE DEATH AND THE CAUSE OF DEATH WERE UNKNOWN, BECAUSE THE EVENT WAS CONFIRMED BY A HOSPITAL WHICH WAS NOT THE STUDY SITE. 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 - GALWAY H7493897024300 11059855

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death TAXUS EXP2 2.5X24MM