BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1871353 · Received October 15, 2010

    Report

    Report Number
    2134265-2010-04632
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    July 2, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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 DURING A STENTING TREATMENT PROCEDURE, A PLAQUE SHIFT OCCURRED. THE PATIENT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASS IA) AND WAS REFERRED FOR CARDIAC CATHETERIZATION THAT REVEALED A 90% STENOSED AND 12MM LONG BIFURCATED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE LESION WAS TREATED WITH PRE-DILATION AND DEPLOYMENT OF A 3.0X16MM TAXUS LIBERTE STENT FOLLOWED BY POST DILATION WITH A 3.5MM NON BSC BALLOON CATHETER RESULTING IN 0% RESIDUAL STENOSIS. HOWEVER, FOLLOWING POST DILATION IT WAS NOTED THAT THERE WAS SOME PLAQUE SHIFT INTO THE DIAGONAL VESSEL. IT WAS TREATED WITH A 1.5MM APEX BALLOON. FINAL ANGIOGRAPHY SHOWED TIMI-3 FLOW WITHOUT DISSECTION OR PERFORATION AND 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON PRASUGREL. IT IS THE OPINION OF THE PHYSICIAN THAT THERE IS A RELATIONSHIP BETWEEN THE PLAQUE SHIFT AND DEPLOYMENT OF THE TAXUS LIBERTE STENT.

    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 13039607

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 3.5MM SPRINTER BALLOON