BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001285 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00611
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    August 21, 2010
    Report Date
    January 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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)(6). SAME CASE AS: 2134265-2011-00610; 2134265-2011-00612. LESION 1 WAS IN THE BIFURCATED LESION LOCATED IN THE 1ST OBTUSE MARGINAL. THE LESION WAS 85% STENOSED, 3.0MM IN DIAMETER AND 34MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X38MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. CULOTTE STENTING (Y-STENTING) WAS PERFORMED FOR THIS BIFURCATED LESION. LESION 2 WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. THE LESION WAS 85% STENOSED, 3.0MM IN DIAMETER AND 24MM LONG. LESION 2 WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X28MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 3 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. THE LESION WAS 85% STENOSED, 3.5MM IN DIAMETER AND 32MM LONG. LESION 3 WAS TREATED WITH PLACEMENT OF A 3.5X38MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. 1 DAY POST-INDEX PROCEDURE, THE PATIENT EXPERIENCED ELEVATED TROPONIN CONSISTENT WITH ARC DEFINITION OF A MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 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 H7493893628300 13209010

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other