BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1234052 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04207
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT DELIVERY BALLOON LENGTH WAS TOO LONG. THE PHYSICIAN DEPLOYED A TAXUS EXPRESS2 2.75X12MM DRUG ELUTING STENT TO THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY AT 14 ATMS. POST DEPLOYMENT THE PHYSICIAN THOUGHT THAT THE COMPLAINT BALLOON LENGTH WAS LONGER THAN THE USUAL FOR THE DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.75X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1