BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1901755 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-05199
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    June 23, 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)(6). DEVICE IS A COMBINATION PRODUCT. (B)(4). 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 2134265-2010-05198. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE INCOMPLETE STENT APPOSITION OCCURRED. TARGET LESION #1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 95% STENOSIS AND WAS 13 MM LONG WITH A REFERENCE DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.50 MM X 16 MM TAXUS LIBERTE STENT. POST-STENT DEPLOYMENT USE OF IVUS REVEALED INCOMPLETE APPOSITION WHICH WAS TREATED WITH POST-DILATATIONS WITH A NON-COMPLIANT BALLOON. RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE 1ST DIAGONAL WITH 100% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND IMPLANTING A 2.25 MM X 12 MM TAXUS LIBERTE STENT. POST-STENT DEPLOYMENT USE OF IVUS REVEALED INCOMPLETE APPOSITION WHICH WAS TREATED WITH POST-DILATATIONS WITH A NON-COMPLIANT BALLOON. RESIDUAL STENOSIS WAS 0%. 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 H7493893612220 13027819

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 2.50X16MM TAXUS LIBERTE STENT