BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2770486 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-06232
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 13, 2012
    Report Date
    September 5, 2012
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(4). SAME CASE AS MDR ID #S 2134265-2012-06230 AND 2134265-2012-06231. IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, TARGET VESSEL REVASCULARIZATION OCCURRED. ON AN UNKNOWN DATE, THE SUBJECT HAD THREE TAXUS ELEMENT STENTS PLACED (2.50 X 20MM, 3.00 X 24MM, AND 3.50 X 16MM) IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. IN (B)(6) 2012, THE SUBJECT UNDERWENT ANGIOGRAPHY AND REVASCULARIZATION OF THE MID LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ UNK571

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention