BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1801247 · Received August 16, 2010

    Report

    Report Number
    2134265-2010-03475
    Event Type
    Injury
    Date Received
    August 16, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2010-03470. IT WAS REPORTED THAT POST-DRUG ELUTING STENTING TREATMENT PROCEDURE, MYOCARDIAL INFARCTION OCCURRED. IN 2004, THE PATIENT HAD A TAXUS EXPRESS2 2.5X24MM STENT AND A TAXUS EXPRESS2 3.0X28MM STENT IMPLANTED IN AN UNSPECIFIED VESSEL. SINCE THE PROCEDURE, IT IS REPORTED THE PATIENT HAS HAD SEVERAL INFARCTS. THE PHYSICIAN REPORTED THAT UPON FOLLOW-UP IT WAS FOUND THE STENT WERE NOT "INFLATED PROPERLY AND THERE WERE PROBLEMS WITH THE STENTS." NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493896828300 6498324

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TAXUS EXPRESS2 2.5X24MM