BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL DRUG ELUTING STENT

    MDR report key: 727735 · Received June 16, 2006

    Report

    Report Number
    6000089-2006-01175
    Event Type
    Death
    Date Received
    June 16, 2006
    Date of Event
    March 17, 2006
    Report Date
    May 24, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND CO IS NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    CLINICAL STUDY: FOURTY FIVE WEEKS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPIRED. THE INDEX PROCEDURE TREATED 1 DE NOVO TARGET LESION. THE TARGET LESION WAS A 3.0MM VESSEL DIAMETER, 10MM LONG, WITH NO CALCIFICATION, 50% STENOSIS, OSTIAL LESION IN THE LEFT MAIN ARTERY AND EXTENDING INTO THE PROXIMAL CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED WITH AN ANGIOPLASTY BALLOON AT 16 ATMS WITH A POST DILATATION STENOSIS OF 20%. THE PHYSICIAN IMPLANTED 1 TAXUS EXPRESS2 3X20MM DRUG-ELUTING STENT (DBS) AT 14 ATMS. POST-TREATMENT, THE LESIONS WERE 5% STENOSIS AND TIMI 3 FLOW. THE PT WAS DISCHARGED ONE DAY POST-INDEX PROCEDURE ON ASPIRIN AND PLAVIX. THE PT UNDERWENT OPEN HEART SURGERY IN 2006. THE PT HAD MULTIPLEK SYSTEM FAILURE POST SURGERY AND EXPIRED. A RELATIONSHIP TO THE STENT HAS NOT BEEN ESTABLISHED. AS AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL DRUG ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X20MM 7203019

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death