BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2961732 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00559
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 16, 2013
    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 COMBINATION PRODUCT. (B)(6). DEVICE EVALUATION BY MANUFACTURER: 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) CLINICAL STUDY. IT WAS REPORTED POST A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPERIENCED ANGINA. IN (B)(6) 2010, THE PATIENT PRESENTED WITH MID STERNAL CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH, DIAPHORESIS, NAUSEA AND VOMITING. THE PATIENT WAS GIVEN NARCOTIC ANALGESIA FOR THE SEVERE CHEST PAIN. ELECTROCARDIOGRAPHY REVEALED CONSISTENT CHANGES WITH ACUTE ANTEROLATERAL AND ANTERIOR SEPTAL MYOCARDIAL INFARCTION. THE PATIENT WAS DIAGNOSED WITH Q WAVE ST ELEVATION MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE PATIENT WAS ADMINISTERED FENTANYL FOR SEDATION AND COMFORT. THE 100% STENOSED AND 12MM LONG DE-NOVO TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.0X20MM TAXUS LIBERTE STNET, RESULTING IN 0% RESIDUAL STENOSIS FOLLOWING POST DILATION. TWO DAYS LATER THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013 THE PATIENT PRESENTED WITH TWO EPISODES OF CHEST PAIN. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED THE FOLLOWING DAY. A 70% STENOSIS WAS NOTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.0X18 NON BSC DRUG ELUTING STENT, RESULTING IN 0% RESIDUAL STENOSIS FOLLOWING POST DILATION. THE FOLLOWING DAY THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65602 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620300

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention