BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1896919 · Received November 11, 2010

    Report

    Report Number
    2134265-2010-04930
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. 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

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A VESSEL OCCLUSION AND MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2008, THE LESION BEING TREATED WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RAMUS. A 3.00X12MM TAXUS EXPRESS2 STENT WAS IMPLANTED. IN (B)(6) 2010, THE PATIENT BEGAN EXPERIENCING CHEST PAIN. IN (B)(6) 2010, A MYOCARDIAL INFARCTION WAS INITIALLY DIAGNOSED BASED ON TROPONIN LEVELS. ANGIOGRAPHY IDENTIFIED THE 'SVG WAS OCCLUDED, BUT THERE WERE 2 OPEN VESSELS'. BECAUSE OF THE '2 OPEN VESSELS' NO INTERVENTION WAS PERFORMED. THE PATIENT'S STATUS IS REPORTED AS DOING WELL.

    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 H7493896812300 11071416

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other