BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1864011 · Received October 11, 2010

    Report

    Report Number
    2134265-2010-04594
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    IT WAS FURTHER REPORTED THAT THE PATIENT HAS A HISTORY OF ANGINA SYMPTOMS GOING BACK TO 2000 THAT INVOLVE EPIGASTRIC CHEST PAIN THAT OCCUR DURING PERIODS OF INACTIVITY AND SEEM TO GET BETTER WITH WALKING. PRIOR TO THE INDEX PROCEDURE, THE STRESS ECHOCARDIOGRAM INDICATED THE PRESENCE OF INFERIOR ISCHEMIA. AT THE TIME OF THE EVENT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED EPIGASTRIC CHEST PAIN THAT WOKE HIM FROM SLEEP. IT WAS A NON-RADIATING, TIGHT SENSATION ASSOCIATED WITH BELCHING. THE PAIN WAS NOTED TO DECREASE WHEN THE PATIENT GOT UP AND WALKED AND RETURNED UPON LYING BACK DOWN. IT WAS DESCRIBED AS BEING SIMILAR TO WHAT HE EXPERIENCED IN (B)(6) 2010. THE PATIENT WAS ADMITTED WITH CRESCENDO ANGINA CHEST PAIN. PEAK CARDIAC ENZYMES WERE REPORTED TO BE: CK OF 130 U/L (NORMAL: 35-232 U/L), CK-MB OF 1.2 NG/ML (NORMAL: 0.0-3.6 NG/ML), AND TROPONIN I OF < 0.4 NG/ML (NORMAL: <= 0.04 NG/ML). ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS ALONG WITH PROXIMAL STENT EDGE STENOSIS. THE LESION WAS PREDILATED PRIOR TO PLACEMENT OF THE PROMUS STENT. THE PATIENT WAS DISCHARGED 1 DAY LATER IN STABLE CONDITION ON PREVIOUSLY PRESCRIBED PRASUGREL-10MG AND ASPIRIN, WITH A NOTE THAT THE ASPIRIN WAS INCREASED TO 325MG.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, CHEST PAIN AND RESTENOSIS OCCURRED. DUE TO A POSITIVE STRESS TEST, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION. A 95% STENOSED AND 20MM LONG "NON COMPLEX" TARGET LESION WAS REVEALED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH TIMI-2 FLOW. IT WAS NOT HEAVILY CALCIFIED OR HEAVILY TORTUOUS. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X20MM TAXUS LIBERTE ATOM STENT FOLLOWED BY POST DILATION USING A 2.0MM BALLOON AT 16 ATM. RESIDUAL STENOSIS WAS 0% AND TIMI-3 FLOW WAS RESTORED. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. EIGHTY FOUR DAYS LATER, THE PATIENT PRESENTED WITH CARDIAC CHEST PAIN. CARDIAC ENZYMES WERE NEGATIVE. CARDIAC CATHETERIZATION REVEALED A 90% STENOSED AND 12MM LONG LESION IN THE PROXIMAL RCA. THIS WAS REPORTED TO BE IN STENT RESTENOSIS. TIMI FLOW WAS "3". IT WAS TREATED WITH PLACEMENT OF A PROMUS STENT WITHOUT COMPLICATION RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW WAS MAINTAINED. THE EVENT IS REPORTED TO BE "COMPLETELY RESOLVED". IT IS THE OPINION OF THE PHYSICIAN THAT THE EVENT IS POSSIBLY RELATED TO THE TAXUS LIBERTE STENT.

    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 H7493893620220 12729590

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R