BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1901728 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-05201
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, INCOMPLETE APPOSITION OF THE STENT OCCURRED. THE INDEX PROCEDURE TREATED THE 70% STENOSED, 2.5X9MM TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. USING A DIRECT STENTING TECHNIQUE, A 2.5X16MM TAXUS LIBERTE STENT WAS PLACED. POST IVUS WAS PERFORMED REVEALING INCOMPLETE APPOSITION OF THE STENT. TREATMENT CONSISTED OF ADDITIONAL POST DILATIONS WITH A NON-COMPLIANT BALLOON RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY 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 H7493893616250 13168474

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention