BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2171928 · Received July 22, 2011

    Report

    Report Number
    2134265-2011-02998
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    March 8, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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)(6). SAME CASE AS: 2134265-2011-02996, 2134265-2011-02997. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. LESION 1 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 80% STENOSED, 3.0MM IN DIAMETER AND 38MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.0X38MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. LESION 2 WAS LOCATED IN THE PROXIMAL RCA. THE LESION WAS 70% STENOSED, 3.0MM IN DIAMETER AND 14MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.0X16MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. IT WAS NOTED THAT THE TWO STENTS IN THE RCA WERE PLACED IN AN OVERLAPPING FASHION. LESION 3 WAS A BIFURCATED LESION LOCATED IN THE 2ND OBTUSE MARGINAL (OM). THE LESION WAS 100% STENOSED, 2.25MM IN DIAMETER AND 27MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X28MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. DURING THE INDEX PROCEDURE, MODERATE RECOIL WAS NOTED AFTER INFLATION WITH A 1.5X20MM APEX PUSH BALLOON IN THE OCCLUDED 2ND OM. A NON-BSC GUIDE WIRE WAS INADVERTENTLY PULLED BACK AND REPLACED WITH ANOTHER GUIDE WIRE USING A 2.0X20MM APEX BALLOON FOR SUPPORT. A MODERATE RECOIL WAS ALSO NOTED AFTER INFLATION WITH THE 2.0X20MM APEX BALLOON WHICH WAS USED FOR SUPPORT. THE RECOIL WAS TREATED WITH NITROGLYCERIN. THE TAXUS LIBERTE STENT WAS PLACED IN THE 2ND OM. RESIDUAL STENOSIS WAS 0%. (B)(6) POST INDEX PROCEDURE, CARDIAC ENZYMES WERE ELEVATED CONSISTENT WITH A MYOCARDIAL INFARCTION WITH NO ISCHEMIC SYMPTOMS NOTED. NO ACTION WAS TAKEN AND THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED ON PRASUGREL.

    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 13946877

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other