BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1033360 · Received April 24, 2008

    Report

    Report Number
    2134265-2008-01180
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    December 12, 2007
    Report Date
    April 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF AVAILABLE INFO RELATED TO THIS EVENT, THERE IS NO EVIDENCE TO INDICATE THE STENT MALFUNCTIONED OR FAILED TO PERFORM TO SPEC. ALLERGIC REACTION IS A KNOWN RISK FACTOR OF CARDIOVASCULAR STENTING AND HAS BEEN CLEARLY IDENTIFIED AS A POTENTIAL ADVERSE EVENT IN THE PROD DIRECTIONS FOR USE (DFU) OF DRUG ELUTING STENTING (DES) DEVICES. WHILE ALLERGIC REACTION IS A RISK FACTOR ASSOCIATED WITH VASCULAR STENTING, THE RISK TO BENEFIT RATIO GREATLY FAVORS PT BENEFIT. UNFORTUNATELY, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE ALLERGIC REACTION IN THIS COMPLAINT EVENT. KNOWN POSSIBLE CAUSES OF ALLERGIC REACTIONS FOLLOWING CORONARY STENTING PROCEDURES INCLUDE, ANTI-COAGULANT AND/OR ANTITHROMBOTIC THERAPY, CONTRAST MEDIUM OR STENT MATERIALS. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED AS PER THE TAXUS EXPRESS2 DIRECTIONS FOR USE (DFU). MYOCARDIAL INFARCTION IS A POTENTIAL ADVERSE EVENT. AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MFG RECORD FOUND NO ANOMALIES OR DEVIATIONS. THE MOST PROBABLE ROOT CAUSE OF THESE EVENTS WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2008-01181, -01182. TAXUS EXPRESS2 POSTMARKET SURVEILLANCE STUDY. THIS COMPLAINT IS NOW REPORTABLE BASED ON ADD'L INFO REC'D ON 04/04/2008. IT WAS REPORTED THAT ONE DAY FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE PT EXPERIENCED A MYOCARDIAL INFARCTION. THE PT PRESENTED FOR TREATMENT WITH STABLE ANGINA. THE LESION WAS CIRCUMFLEX AND OBTUSE MARGINAL WITH 75% STENOSIS AND LEFT MAIN 90% STENOSIS. A 2.5X16MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS PLACED AT THE CIRCUMFLEX AND OBTUSE MARGINAL LESION AT 12 ATM. PLACEMENT OF THE STENT WAS CONFIRMED WITH IVUS. (INTRAVASCULAR ULTRASOUND). NEXT, 3.0X24MM AND 3.0X12MM TAXUS EXPRESS2 DRUG ELUTING STENTS WERE PLACED IN THE LEFT MAIN. FOLLOWING POST DILATION OF THE DRUG ELUTING STENTS, THERE WAS 0% RESIDUAL STENOSIS. ONE DAY FOLLOWING THE PROCEDURE, A LATERAL BRANCH BECAME OBSTRUCTED AND CK LEVELS ROSE. TREATMENT WAS NOT NEEDED AND THE PT RECOVERED. THE PT ALSO EXPERIENCED A RASH DUE TO PANALDINE ELEVEN DAYS FOLLOWING THE INITIAL PROCEDURE. PANALDINE WAS CHANGED TO PLAVIX WHICH RESOLVED THE REACTION. THE PHYSICIAN REPORTED THESE EVENTS WERE RELATED TO THE TAXUS STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 2.5X16MM 9714176

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R