BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2012345 · Received March 9, 2011

    Report

    Report Number
    2134265-2011-00636
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    December 2, 2010
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED THEREFORE A TECHNICAL ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE 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) STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE THE PATIENT ENCOUNTERED STABLE ANGINA. TARGET LESION 1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 75% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT WITH A 3.50X38MM (B)(4) STENT. POST DILATATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. 3 MONTHS LATER THE PATIENT PRESENTED WITH STABLE ANGINA. THE EVENT WAS RESOLVED WITH OUT RESIDUAL EFFECTS. THE NEXT DAY THE PATIENT WAS ADMITTED WITH AN EPISODE OF STABLE ANGINA. 7 DAYS AFTER THAT THE PATIENT UNDERWENT A CABG PROCEDURE WITH SAPHENOUS VEIN GRAFT TO THE LEFT POSTERIOR DESCENDING ARTERY, 1ST OBTUSE MARGINAL, 2ND OBTUSE MARGINAL AND A DIAGONAL VESSEL AND LIMA GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT WAS DISCHARGED 2 DAYS LATER.

    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 H7493893638350 0012831541

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention