BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM¿

    MDR report key: 3051358 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02636
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 10, 2013
    Report Date
    March 15, 2013
    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

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: 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) CLINICAL STUDY. IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST DISCOMFORT AND EXERTIONAL DYSPNEA. THE PATIENT PRESENTED WITH CLASS 1 STABLE ANGINA IN (B)(6) 2010 AND UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE WHICH REVEALED TWO TARGET LESIONS. TARGET LESION #1 WAS LOCATED IN THE 1ST OBTUSE MARGINAL (OM) WITH 90% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED UNKNOWN STENT AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 32 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS AN OSTIAL LESION LOCATED IN THE PROXIMAL SEGMENT OF SAPHENOUS VEIN GRAFT (SVG) TO 2ND OM WITH 70% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. IT WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 X 20 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGE THE FOLLOWING DAY ON ASPIRIN AND PRASUGREL. ON (B)(6) 2013, THE PATIENT PRESENTED WITH CHEST DISCOMFORT AND EXERTIONAL DYSPNEA. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AND UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED A 90% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED STUDY STENT LOCATED IN THE 1ST OM. THE LESION WAS TREATED WITH PLACEMENT OF A 2.5 X 12 MM RESOLUTE STENT. FOLLOWING POST-DILATATION RESIDUAL RESTENOSIS WAS 0%. IN ADDITION, 70-80% STENOSIS IN PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.5 X 12 MM RESOLUTE STENT WITH 0% RESIDUAL STENOSIS. ON THE FOLLOWING DAY, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149660 TAXUS® LIBERTÉ® ATOM¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632220 0012751924

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention