BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2003313 · Received February 28, 2011

    Report

    Report Number
    2134265-2011-00618
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    August 28, 2010
    Report Date
    February 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. 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). SAME CASE AS MFR#: 2134265-2011-00617, 2134265-2011-00619. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT WAS PRESENTED DUE TO UNSTABLE ANGINA (CCS CLASS 3). CARDIAC CATHETERIZATION REVEALED 2 TARGET LESIONS. THE FIRST WAS LOCATED IN A BIFURCATED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 75% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THIS LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.5X24MM TAXUS LIBERTE STENT. POST DILATATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. THE SECOND WAS LOCATED IN THE RIGHT CORONARY ARTERY WITH 100% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THIS LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF OVERLAPPING A 3.0X32MM AND 3.0X24MM TAXUS LIBERTE STENT. POST DILATATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT HAD ELEVATED CARDIAC ENZYMES CONSISTENT WITH A MYOCARDIAL INFARCTION (PEAK CK= 1589 U/L, ULN = 200, PEAK CK-MB= 16.4 NG/ML). NO ACTION WAS TAKEN AND THE PATIENT WAS DISCHARGED THE SAME 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 H7493893632300 13047604

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other 3.50X24MM TAXUS LIBERTE STENT| 3.00X24MM TAXUS LIBERTE STENT