BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2042520 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01219
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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). SAME CASE AS 2134265-2011-01220. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN AND RESTENOSIS. THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH TOTAL CHRONIC OCCLUSION AND WAS 33 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.25 MM X 28 MM AND 2.25 MM X 24 MM TAXUS LIBERTE STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT DEVELOPED CHEST PAIN. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 70% IN-STENT RESTENOSIS OF THE 1ST OBTUSE MARGINAL. THE PATIENT WAS TREATED WITH AN ANGIOPLASTY BALLOON AND DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893628220 12770604

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 2.25X24MM TAXUS LIBERTE ATOM STENT