BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 622639 · Received July 22, 2005

    Report

    Report Number
    6000089-2005-01018
    Event Type
    Injury
    Date Received
    July 22, 2005
    Date of Event
    June 23, 2005
    Report Date
    June 23, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 HOUR AFTER A DRUG ELUTING STENTING TREATMENT PROCEDURE, AN ACUTE THROMBOSIS OCCURRED. THE TARGET LESION WAS IN THE NON-TORTUOUS, NON-CALCIFIED, 90% STENOTIC, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS ACCESSED VIA THE RADIAL ARTERY AND WAS NOT PREDILATED. THE PHYSICIAN DEPLOYED A 3.00 X 32 MM TAXUS EXPRESS2 DRUG ELUTING STENT. IT IS NOTED THAT THE PATIENT HAD NA ALLERGIC REACTION TO THE CONTRAST MEDIUM WHICH INVOLVED ITCHING. THE PATIENT WAS GIVEN PLAVIX PRE-AND POST-PROCEDURE AND AN LLB/LLLA INHIBITOR DURING THE PROCEDURE. ONE HOUR POST-PROCEDURE THE PATIENT WAS BROUGHT BACK TO THE CATH LAB WITH SHORTNESS OFBRETH. THE LAD WAS OCCLUDED, ANOTHER PERCUTANEOUS INTERVENTION WAS PERFORMED AND AN INTRA AORTIC BALLOON PUMP WAS PLACED. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT RETURNED TO CORONARY CARE. THE PATIENT STATUS IS REPORTED AT `GETTING BETTER' AND IS EXPECTED TO BE RELEASED FROM THE HOSPITAL SHORTLY.

    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% 3.00 X 32 MM 7386259

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention