BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2822743 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06782
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND WORSENING OF CORONARY ARTERY DISEASE (CAD). IN (B)(6) 2010, DUE TO ACUTE CORONARY SYNDROME WITH ELEVATED CK-MB OR POSITIVE TROPONIN AND LAST PAIN LESS THAN 24 HOURS AGO, THE PATIENT UNDERWENT THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE 1ST DIAGONAL BRANCH (DX1) WITH 90% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 2.50X16MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW FOLLOWING POST-DILATION. THE PATIENT DID NOT RECEIVE A PERI-PROCEDURAL LOADING DOSE OF THIENOPYRIDINE MEDICATION AND THE PATIENT DID NOT WANT TO BE ON PLACEBO. THE PATIENT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. IN (B)(6) 2012, THE SUBJECT EXPERIENCED WORSENING OF CAD AND PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF CHEST PAIN. THE PATIENT HAS HAD TWO EPISODES OF CHEST PAIN, MOST RECENT ON THE NIGHT PRIOR TO ADMISSION. THE PATIENT STATED THAT THE PAIN WAS IN THE CENTER OF HIS CHEST AND DESCRIBED IT AS PRESSURE, HEAVINESS WITHOUT SIGNIFICANT SHORTNESS OF BREATH OR RADIATION. THE PATIENT STATED THAT HE HAD A SIMILAR EPISODE ABOUT A MONTH AGO, AND THE PAIN WAS DIFFERENT IN QUALITY AND INTENSITY COMPARED TO THE PAIN HE HAD WHEN HE HAD A MYOCARDIAL INFARCTION. THE PATIENT WAS STARTED ON IMDUR 30.0MG ONE TABLET P.O. DAILY, METOPROLOL 12.5MG ONE TABLET P.O. TWICE DAILY, AND A LONG-LASTING NITROGLYCERIN. THE PATIENT WAS TO FOLLOW UP WITH HIS PRIMARY CARE PHYSICIAN IN ONE WEEK AND CARDIOLOGIST IN 2-3 WEEKS OR AS NEEDED. THE OUTCOME OF THE EVENT IS NOT RECOVERED/NOT RESOLVED AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616250 13172166

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization STARTED ON ASPIRIN 81.0MG| CLOPIDOGREL 75.0MG