BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM¿

    MDR report key: 2823242 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06974
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 3, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED 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). SAME CASE AS MDR ID #2134265-2012-06973. IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, CHEST PAIN OCCURRED. IN (B)(6) 2011, THE SUBJECT PRESENTED WITH STABLE ANGINA (CCS CLASS: 1). CARDIAC CATHETERIZATION WAS RECOMMENDED WHICH REVEALED TWO TARGET LESIONS. TARGET LESION #1 WAS 72% STENOSED AND LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS 7 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.6 MM AND TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 X 16 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS 99% STENOSED AND LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.10 MM AND TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 16 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL, THE FOLLOWING DAY. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH EXERTIONAL CHEST PAIN AND WAS HOSPITALIZED. SIX DAYS LATER, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® ATOM¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616220 13846300

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other