BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2753029 · Received September 20, 2012

    Report

    Report Number
    2134265-2012-05694
    Event Type
    Injury
    Date Received
    September 20, 2012
    Date of Event
    August 22, 2012
    Report Date
    August 24, 2012
    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)(4).DEVICE EVALUATION 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) CLINICAL STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND IN-STENT RESTENOSIS. IN (B)(6) 2011, THE PATIENT PRESENTED WITH CHEST PAIN RADIATING TO RIGHT ARM ASSOCIATED WITH DIAPHORESIS, PALPITATIONS AND SHORTNESS OF BREATH. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 75% STENOSED AND 17 MM LONG DE-NOVO TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 3.3 MM. TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A TAXUS LIBERTE (OTW) 20 X 3.00MM STENT WITH 9% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND PRASUGREL. (B)(6) 2012, 334 DAYS POST INDEX PROCEDURE THE PATIENT PRESENTED WITH RECURRENT CHEST PAIN. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED ON SAME DAY. (B)(6) 2012, 335 DAYS POST INDEX PROCEDURE 90% EDGE STENOSIS OF THE TAXUS LIBERTE (OTW) 20 X 3.00MM STENT PLACED IN PROXIMAL LAD WAS TREATED WITH DIRECT STENT PLACEMENT USING 3.5 X 16 MM PROMUS STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893720300 13524877

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention