BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL DRUG-ELUTING STENT

    MDR report key: 751381 · Received August 14, 2006

    Report

    Report Number
    6000093-2006-01492
    Event Type
    Injury
    Date Received
    August 14, 2006
    Date of Event
    September 16, 2005
    Report Date
    July 17, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNKNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 6000093-2006-01491. IT WAS REPORTED THAT 100 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE PATIENT HAD A TARGET VESSEL REINTERVENTION (TVR). THE INDEX PROCEDURE TREATED 1 DE NOVO TARGET LESION WITH 90% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS NOT PREDILATED. THE PHYSICIAN SUCCESSFULLY IMPLANTED 2 OVERLAPPING STENTS, ONE 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) AT 16 ATMS AND ONE 2.5X16MM TAXUS EXPRESS2 DES AT 12 ATMS. THE PATIENT HAD A PCI OF THE TARGET VESSEL 100 DAYS AFTER THE INDEX PROCEDURE DUE TO RESTENOSIS OF THE LAD STENT. THE PATIENT WAS ON PLAVIX AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL DRUG-ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 2.5X16MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R