BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2040411 · Received April 5, 2011

    Report

    Report Number
    2134265-2011-01046
    Event Type
    Death
    Date Received
    April 5, 2011
    Date of Event
    December 26, 2010
    Report Date
    March 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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)(6) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT DIED. THE PATIENT PRESENTED WITH AN ACUTE ST ELEVATION MI AND A STAGED INDEX PROCEDURE WAS PLANNED. IN (B)(6) 2009, TWO NON BSC STENTS (2.5X24MM 2.5X30MM) WERE PLACED IN THE THE RIGHT CORONARY ARTERY. THE PATIENT WAS STARTED ON ASPIRIN AT DISCHARGE. IN (B)(6) 2010, THE PATIENT RETURNED AND A 2.25X16MM TAXUS EXPRESS STENT WAS PLACED IN THE DISTAL CIRCUMFLEX ARTERY. THE PATIENT WAS DISCHARGED THE NEXT DAY ON CLOPIDOGREL. THE SITE REPORTED THAT DURING THE 15 MONTH FOLLOW UP CALL TO THE PATIENT, IT WAS DISCOVERED THAT THE PATIENT DIED IN (B)(6) 2010 AT AN OUTSIDE HOSPITAL. THE PATIENT'S SPOUSE WITNESSED THE PATIENT GO DOWN AND INITIATED CPR. THE PATIENT WAS TAKEN TO THE HOSPITAL BY AMBULANCE, A CODE WAS CALLED AND THE PATIENT WAS PRONOUNCED DEAD. NO AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS LISTED AS CARDIAC ARREST. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY STENT.

    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 H7493897016220 12593547

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death 2.5X30MM ENDEVOUR STENT| 2.5X24MM ENDEVOUR STENT