BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2070003 · Received April 26, 2011

    Report

    Report Number
    2134265-2011-01530
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    November 10, 2010
    Report Date
    March 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT (B)(6). DEVICE EVALUATED BY MFR: 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) CLINICAL STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (B)(6) AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED AN 85% STENOSED AND 22 MM LONG TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. IT WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.0X24MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 9% RESIDUAL STENOSIS. ONE DAY LATER, THE PATIENT DEVELOPED CHEST PAIN AND DYSPNEA. CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND THE PATIENT WAS DIAGNOSED AS HAVING A MYOCARDIAL INFARCTION. NO TREATMENT WAS NOTED AND THE EVENT RESULTED IN A PROLONGED HOSPITALIZATION. ONE DAY LATER, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893724300 13626880

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization