BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT

    MDR report key: 754727 · Received August 23, 2006

    Report

    Report Number
    6000093-2006-01584
    Event Type
    Injury
    Date Received
    August 23, 2006
    Date of Event
    December 25, 2005
    Report Date
    July 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    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 APPROX EIGHT MONTHS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PT HAD A MYOCARDIAL INFARCTION. THE INDEX PROCEDURE TREATED 1 DE NOVO TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREDILATED WITH AN ANGIOPLASTY BALLOON AT 10 ATMS. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 3X24MM TAXUS EXPRESS2 DRUG-ELUTING STENT AT 12 ATMS. THE PT WA DISCHARGED 3 DAYS POST-INDEX PROCEDURE ON PLAVIX. INFO RECEIVED INDICATES THE "PT STATES HAD "HEART ATTACK" IN 2005, RESULTING IN CORONARY ARTERY BYPASS SURGERY (CABG). NO OTHER HEART PROBLEMS SINCE CABG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X24MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R