BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 513260 · Received February 26, 2004

    Report

    Report Number
    6000089-2004-00091
    Event Type
    Injury
    Date Received
    February 26, 2004
    Report Date
    January 28, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT DEVELOPED AN ACUTE THROMBOSIS OF THE STENT. THE PT HAD A TAXUS EXPRESS2 2.25. X 8 MM DRUG ELUTING STENT PLACED IN THE LAD. THREE DAYS LATER, PT WAS BROUGHT BACK TO THE CATH LAB AT WHICH TIME, ANGIOGRAPHY REVEALED ACTUE THROMBOSIS OF THE TAXUS EXPRESS2 STENT. PT THEN UNDERWENT A SECOND TAXUS STENT PLACEMENT AT THE SAME LOCATION IN THE LAD TO TREAT THE STENT THROMBOSIS. WITHIN A WEEK, THE STENT THROMBOSED AGAIN, LEADING TO ANOTHER URGENT ANGIOGRAM. AT THAT TIME, PT WAS SENT FOR EMERGENT CARDIAC BYPASS SURGERY. PT SUBSEQUENTLY RECOVERED AND WAS DISCHARGED HOME. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. SAME CASE AS MFR'S #6000098 2004 00090.

    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% 2.25 X 20 MM 6011293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention