BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1781761 · Received August 3, 2010

    Report

    Report Number
    2134265-2010-03572
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - (B)(4). 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). IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED SLOW FLOW. THE UNSPECIFIED TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL (OM). THE LESION WAS 80% STENOSED, 2.5MM IN DIAMETER AND 14.0MM LONG. THE LESION WAS PREDILATED AND TREATED WITH THE PLACEMENT OF A 2.5X16MM LIBERTE STENT. RESIDUAL STENOSIS WAS 10%. DURING THE PROCEDURE, A SIDE BRANCH EVENT OF SLOW FLOW/NO FLOW OCCURRED. PRE-STENT HAD A TIMI 3 FLOW OF THE SIDE BRANCH, POST-STENT TIMI 2 FLOW. THE PATIENT WAS DISCHARGED 1 DAY 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 - GALWAY H7493893616250 12894801

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR