BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1884149 · Received October 27, 2010

    Report

    Report Number
    2134265-2010-04676
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED AT THE TIME OF THE EVENT WITH DISCOMFORT IN HER THROAT WITH RADIATION TO HER RIGHT SHOULDER. DISCOMFORT OCCURRED WHILE EXERCISING AND WAS TRANSIENT. AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH UNSTABLE ANGINA (BRUNWALD CLASSIFICATION IB).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED AND THE PATIENT UNDERWENT SURGERY. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS 90% STENOSED, 2.3MM IN DIAMETER AND 24MM LONG. DURING THE INDEX, IT WAS INDICATED THAT SOME IRREGULARITIES WERE NOTED IN THE OSTIUM. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X28MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, A STRESS TEST WAS PERFORMED WITH POSITIVE ISCHEMIA. TWO DAYS LATER, THE CARDIAC CATH REVEALED OSTIUM WAS 80% STENOSED WITH 50% IN-STENT RESTENOSIS IN THE LAD. FIVE DAYS LATER, THE PATIENT WAS SENT FOR A CORONARY ARTERY BYPASS GRAFT SURGERY. THE PATIENT UNDERWENT A JUMP GRAFT OF THE LEFT INTERNAL MAMMARY ARTERY (LIMA) BYPASSING THE DIAGONAL AND LAD LESIONS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 4 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628220 0012724360

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention