BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1771691 · Received July 27, 2010

    Report

    Report Number
    2134265-2010-03256
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    January 13, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE - 2009. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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

    IT WAS REPORTED VIA VOLUNTARY MEDWATCH (B)(6) THAT POST A STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE LESION WAS LOCATED IN THE FIRST DIAGONAL ARTERY. THE LESION WAS TREATED WITH A 2.0X6MM FLEXTOME CUTTING BALLOON. A 2.25X8MM TAXUS LIBERTE ATOM DRUG ELUTING STENT WAS DEPLOYED IN THE LESION. THE PATIENT WAS DISCHARGED ON PLAVIX AND ASPIRIN. AN UNDETERMINED TIME LATER, THE PATIENT PRESENTED WITH AN ST ELEVATION MYOCARDIAL INFARCTION. THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) ADJACENT TO AND INCLUDING THE OSTIUM OF THE FIRST DIAGONAL ARTERY WAS OCCLUDED WITH THROMBUS. THE PROXIMAL LAD WAS PREDILATED WITH A 2.5X15MM APEX BALLOON AND THE FIRST DIAGONAL ARTERY WAS PREDILATED WITH A 2.5X12MM APEX BALLOON. THE PROXIMAL LAD WAS FURTHER DILATED WITH A 3.0X15MM APEX BALLOON USING A KISSING BALLOON TECHNIQUE. DURING THE PROCEDURE THE PATIENT WAS MEDICATED WITH ASPIRIN, PLAVIX, ANGIOMAX AND REOPRO. NO PATIENT COMPLICATIONS WERE REPORTED. POST PROCEDURE, ANGIO REVEALED 0% RESIDUAL STENOSIS AND BRISK TIMI III DISTAL FLOW IN BOTH VESSELS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PLAVIX.

    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 H749389368220 12739826

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 2.0X6MM FLEXTOME CUTTING BALLOON