BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1883761 · Received October 27, 2010

    Report

    Report Number
    2134265-2010-04895
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    June 2, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (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

    SAME CASE AS MFR#: 2134265-2010-04896. (B)(4) STUDY. IN (B)(6) 2010, IT WAS REPORTED THAT POST PROCEDURE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE FIRST TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 90% STENOSIS AND WAS 15MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE LESION BEING TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75X28MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE SECOND TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 70% STENOSIS AND WAS 8MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THIS LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X12MM TAXUS LIBERTE STENT. ONE DAY POST PROCEDURE, THE PATIENT HAD ELEVATED CARDIAC ENZYMES CONSISTENT WITH PROTOCOL DEFINITION OF AN MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN AND THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. RELATIONSHIP TO INDEX PROCEDURE PER INVESTIGATOR IS HIGHLY PROBABLE.

    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 H7493893628270 13097163

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 2.50X12MM TAXUS LIBERTE STENT