BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1905190 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05235
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THERE WERE TWO TARGET LESIONS TREATED AT THE INDEX PROCEDURE. THE FIRST WAS A 75% STENOSED AND 46MM LONG LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. IT WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.5X38MM AND 3.5X12MM TAXUS LIBERTE STENT RESULTING IN 9% RESIDUAL STENOSIS. THE SECOND WAS AN 80% STENOSED AND 18MM LONG LESION LOCATED IN THE FIRST OBTUSE MARGINAL (OM1) WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. IT WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.75X20MM TAXUS LIBERTE STENT RESULTING IN 9% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT DEVELOPED CARDIAC CHEST PAIN AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A STENT THROMBOSIS IN THE OM1 RESULTING IN 98% OCCLUSION OF THE ARTERY. ONE DAY LATER, THE PATIENT WAS TREATED WITH ANGIOPLASTY AND DRUG ELUTING STENT PLACEMENT RESULTING IN 9% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS UNRELATED TO THE TAXUS LIBERTE STENTS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED FOR EVALUATION OF SHORTNESS OF BREATH AND CHEST PALPITATIONS WORSENING OVER THE LAST 6 MONTHS. CARDIAC ENZYMES (CK AND CK-MB) WERE ELEVATED AND THE SUBJECT WAS REFERRED FOR THE INDEX PROCEDURE CARDIAC CATHETERIZATION. AT THE TIME OF THE EVENT, THE PATIENT EXPERIENCED IN STENT RESTENOSIS AND NOT STENT THROMBOSIS AS PREVIOUSLY REPORTED. THE PATIENT PRESENTED WITH COMPLAINTS OF INCREASED SHORTNESS OF BREATH AND BURNING IN HER MID CHEST WITH CHRONIC FATIGUE. INITIAL CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS AND EKG REVEALED ANTEROLATERAL T WAVE CHANGES. ANGIOGRAPHY CONFIRMED 98% DIFFUSE IN STENT RESTENOSIS OF THE OBTUSE MARGINAL 1 (OM1) AND 20% IN STENT RESTENOSIS OF THE MID RCA. THE OM1 WAS TREATED WITH PLACEMENT OF A 2.75X18MM PROMUS DRUG ELUTING STENT AND POST DILATION RESULTING IN LESS THAN 10% RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893720270 13136403

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 3.5X38MM TAXUS LIBERTE STENT| 3.5X12MM TAXUS LIBERTE STENT