BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 844630 · Received April 30, 2007

    Report

    Report Number
    6000093-2007-00842
    Event Type
    Injury
    Date Received
    April 30, 2007
    Date of Event
    December 24, 2006
    Report Date
    April 3, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIO
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES STATED IN THE COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME CASE AS MDR#6000093-2007-000843. SEE ATTACHED MEDWATCH #MW1042280 (2 PAGES). IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THE PHYSICIAN IMPLANTED 2 TAXUS EXPRESS2 DRUG ELUTING STENTS OF UNK SIZE IN THE LEFT ANTERIOR DESCENDING (LAD). APPROX 2 YEARS LATER, THE PT PRESENTED WITH THROMBOSIS WITH EJECTION FRACTION OF 25% AFTER PTCA. A NON-BSC STENT OF UNK SIZE WAS PLACED TO TREAT THE THROMBOSIS. THE PT HAD STOPPED PLAVIX ONE YEAR PRIOR TO THE EVENT. FURTHER INFO HAS BEEN REQUESTED BUT HAD NOT BEEN RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention