BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2070211 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01475
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    August 4, 2010
    Report Date
    March 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND AND MET ALL SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2011-01476. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED AN MYOCARDIAL INFARCTION. THE INDEX PROCEDURE TREATED TWO TARGET LESIONS. THE 1ST LESION WAS A 95% STENOSED, 2.6X10MM TARGET LESION LOCATED IN THE SAPHENOUS VEIN GRAFT OF THE 2ND OBTUSE MARGINAL BRANCH. TREATMENT CONSISTED OF PRE DILATION , THE PLACEMENT OF A 2.5X12MM TAXUS LIBERTE STUDY STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE 2ND LESION WAS A 90% STENOSED, 2.6X15MM TARGET LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY. TREATMENT CONSISTED OF PRE-DILATION AND THE PLACEMENT OF A 2.5X20MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE NEXT DAY, THE PATIENT EXPERIENCED A RISE IN TROPONIN LEVELS. NO ACTION WAS TAKEN AND THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED LATER 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 H7493893612250 13227263

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 2.5X20 TAXUS LIBERTE