BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT

    MDR report key: 757855 · Received September 5, 2006

    Report

    Report Number
    6000093-2006-01736
    Event Type
    Injury
    Date Received
    September 5, 2006
    Date of Event
    June 8, 2006
    Report Date
    August 8, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES, EXPERIENCED DURING THE PROCEDURE, COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT ON THE SAME DAY OF A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PT HAD A NON-Q WAVE MYOCARDIAL INFARCTION (MI). THE INDEX PROCEDURE TREATED 1 DE NOVO TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. PRE AND POST IVUS WAS USED. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 3.5X16MM TAXUS EXPRESS2 DRUG-ELUTING STENT AT 17 ATMS. THE PT HAD A NON-Q WAVE MI ON THE SAME DAY AS THE INDEX PROCEDURE. HE WAS DISCHARGED 1 DAY POST INDEX PROCEDURE ON ASPIRIN AND PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.5X16M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L