BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1243015 · Received November 21, 2008

    Report

    Report Number
    2134265-2008-04424
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE MFG DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PROD SPECS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT 727 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE PT WAS ADMITTED FOR UNSTABLE ANGINA. THE INDEX PROCEDURE TREATED THE LMCA (LEFT MAIN CORONARY ARTERY WITH A 3.5 X 8 MM TAXUS EXPRESS2 STENT. A DISTAL RCA (RIGHT CORONARY ARTERY) LESION WAS ALSO IDENTIFIED, BUT WAS NOT TREATED. THE PT PRESENTED 727 DAYS FOLLOWING THE INDEX PROCEDURE WITH UNSTABLE ANGINA AND WAS ADMITTED. ON DAY 731 THE PT UNDERWENT REVASCULARIZATION DUE TO 90% IN-STENT RESTENOSIS OF THE LMCA. TREATMENT RESULTED IN <30% RESIDUAL STENOSIS. THE INVESTIGATOR ASSESSED THIS EVENT AS HAVING A HIGHLY PROBABLE RELATIONSHIP TO THE TAXUS EXPRESS2 STENT.

    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 3.5 X 8 MM 8785803

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R