BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3243373 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04983
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    March 21, 2012
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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)(4). IT WAS REPORTED THAT SUBSEQUENT TO A CORONARY STENTING TREATMENT PROCEDURE, PATIENT EXPERIENCED UNSTABLE ANGINA AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2011, THE SUBJECT PRESENTED WITH NON ST ELEVATION MYOCARDIAL INFARCTION AND UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED A LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH PRE-EXISTING THROMBUS, 90% STENOSIS AND WAS 25MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4 MM. IT WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.00 X 32 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. IN (B)(6) 2011, THE SUBJECT EXPERIENCED COMMUNITY ACQUIRED PNEUMONIA. IN (B)(6) 2011, THE SUBJECT EXPERIENCED ABDOMINAL AORTIC ANEURYSM. TWO WEEKS PRIOR TO HOSPITALIZATION, THE SUBJECT UNDERWENT TRANSESOPHAGEAL ECHOCARDIOGRAM WHICH REVEALED MILD AORTIC STENOSIS; SUBJECT HAD ALSO BEEN DIAGNOSED WITH LEFT LUNG CANCER. AT THE TIME OF THE EVENT, THE SUBJECT WAS ON ASPIRIN AND OPEN LABEL PRASUGREL. THE SUBJECT¿S ANGIOGRAPHIC FILMS REVEALED THREE VESSEL CORONARY DISEASE AND CABG WAS RECOMMENDED. ON (B)(6) 2012, THE SUBJECT PRESENTED WITH THE COMPLAINTS OF CHEST PAIN, WAS HOSPITALIZED ON THE SAME DAY AND WAS TREATED WITH CABG X 3 WITH LIMA TO LAD, SVG TO OM2 AND SVG TO R-PDA. THE EVENT WAS CONSIDERED RECOVERING/ RESOLVING AND THE SUBJECT WAS DISCHARGED ON ASPIRIN 6 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344323 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632400 13414121

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R