BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 580321 · Received March 9, 2005

    Report

    Report Number
    6000093-2005-00275
    Event Type
    Death
    Date Received
    March 9, 2005
    Date of Event
    January 24, 2005
    Report Date
    February 7, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS MFR # 6000093-2005-00276. IT WAS REPORTED THAT 13 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPIRED. THE PT WAS ENROLLED IN THE ARRIVE STUDY IN JAN 2005. TARGET LESION 1 WAS IDENTIFIED IN THE PROXIMAL LAD WITH 100% STENOSIS AND A 3.0 MM REFERENCE VESSEL DIAMETER. TARGET LESION 1 WAS TREATED WITH PREDILATATION AND PLACEMENT OF 2 TANDEM TAXUS STENTS, 3.0 X 16 MM AND 2.75 X 12 MM. RESIDUAL STENOSIS WAS 0%. POST-CATH, CARDIAC ENZYMES PEAKED WITH TROPONIN GREATER THAN 100 AND CPK AT 3477. THE PT WAS DISCHARGED IN JAN 2005 ON PLAVIX AND ASA. TEN DAYS LATER 13 DAYS POST ARRIVE PROCEDURE), THE PT WAS URGENTLY TAKEN TO THE ER AFTER EXPERIENCING LOSS OF CONSCIOUSNESS WHILE RIDING IN THE CAR WITH THEIR SPOUSE. THE PT WAS UNRESPONSIVE AND WITHOUT RESPIRATIONS FOR APPROXIMATLEY 15-30 MINUTES. FULL CODE WAS PERFORMED AND PER ER NOTE, RESUSCITATIVE EFFORTS WERE UNSUCCESSFULLY. THE CODE WAS CALLED AND THE PT EXPIRED SAME DAY. THE CAUSE OF DEATH PER ER NOTE "IS PRESUMED TO BE CARDIAC, PROBABLY RELATING TO AN ARRHYTHMIA DUE TO UNDERLYING RECURRENT MYOCARDIAL INFARCTION." NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 2.75 X 12 MM 7016921

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death