BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904566 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05218
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A 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

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ATYPICAL CHEST PAIN. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS 99% STENOSED, 12MM LONG AND 3.5MM IN DIAMETER. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X16MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. ONE DAY POST INDEX PROCEDURE, THE PATIENT EXPERIENCED ATYPICAL CHEST PAIN AND WAS ADMITTED. CARDIAC CATHETERIZATION WAS PERFORMED. THE STENT WAS PATENT AND WIDELY OPEN. NO ACTION WAS TAKEN AND THE PATIENT WAS DISCHARGED 2 DAYS LATER 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 H7493893616300 0013039607

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention