BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 660266 · Received January 3, 2006

    Report

    Report Number
    6000093-2005-01397
    Event Type
    Injury
    Date Received
    January 3, 2006
    Date of Event
    November 30, 2005
    Report Date
    November 30, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME MANUFACTURE# 6000093-2005-01396. 9 MONTHS AFTER A DRUG ELUTING STENT TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE PHUSICIAN SUCCESSFULLY DEPLOYED TWO UNKNOWN SIZE TAXUS EXPRESS2 DRUG ELUTING STENTS IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS DISCHARGED WITH A REGIMEN OF PLAVIX. 9 MONTHS AFTER THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN ACUTE MI. ADVANCED LIFE SUPPORT WAS INITIATED AND THE PATIENT WAS BROUGHT TO THE CATH LAB. A THROMBOSIS WAS NOTED AND THE PHYSICIAN DEPLOYED AN UNKNOWN SIZE BARE METAL LIBERTE STENT BETWEEN THE TWO PREVIOUSLY PLACED TAXUS STENTS. 1 WEEK PRIOR TO THIS EVENT. NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS "FINE". MADE SEVERAL ATTEMPTS IN ONE MONTH TO GET ADDITIONAL INFORMATION WITHOUT SUCCESS.

    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 UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention