BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2833779 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-07067
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS 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

    (B)(4). SAME CASE AS MDR# 2134265-2012-07070 AND MDR# 2134265-2012-07072. SAME PATIENT AS MDR# 2134265-2012-07068 AND MDR# 2134265-2012-07069. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND A POSITIVE STRESS TEST. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH CARDIOMYOPATHY, AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE FIRST, 80% STENOSED, 30MM X 2.75MM, DE-NOVO TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 32 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE SECOND, 80% STENOSED, 28MM X 2.75MM, DE-NOVO TARGET LESION WAS LOCATED IN THE MID LAD. THE SECOND TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 28 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE THIRD, 80% STENOSED, 30MM X 2.25MM, DE-NOVO TARGET LESION WAS LOCATED IN THE 2ND DIAGONAL. THE THIRD TARGET LESION WAS TREATED WITH PRE-DILATATION USING A 2.00 X 20 MM APEX BALLOON AND 2.00 X 40 MM APEX BALLOON, RESULTING IN RECOILING. THE 2ND DIAGONAL WAS TREATED WITH PLACEMENT OF A 2.25 X 32 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST DISCOMFORT RADIATING TO NECK AND ARM AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT WAS TAKING ASPIRIN AND HAD NOT TAKEN THE STUDY DRUG PRASUGREL SINCE (B)(6) 2012. CARDIAC ENZYMES WERE ELEVATED AND AN ELECTROCARDIOGRAM REVEALED LEFT VENTRICULAR HYPERTROPHY WITH QRS WIDENING. CARDIAC CATHETERIZATION WAS RECOMMENDED. TWO DAYS LATER, THE LEFT MAIN CORONARY ARTERY (LMCA) AND PROXIMAL LAD WERE TREATED WITH PLACEMENT OF A 3.00 X 12 MM PROMUS ELEMENT STENT. DURING POST-DILATATION WITH A 4.00 X 8 MM APEX BALLOON, THE BALLOON RUPTURED AT 22 ATMS. IVUS REVEALED A WIDELY PATENT STENT IN THE LMCA AND PROXIMAL LAD WITH GOOD STENT APPOSITION. THE 80-90% STENOSIS LOCATED IN DISTAL LAD WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 20 MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. THE 60-70% STENOSIS NOTED IN THE MID LEFT CIRCUMFLEX ARTERY WAS TREATED WITH PLACEMENT OF A 2.75 X 16 MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. THE 80% STENOSIS IN RIGHT POSTEROLATERAL (RPL) BRANCH WAS TREATED WITH PLACEMENT OF A 2.75 X 12 MM PROMUS ELEMENT STENT. THE 30% STENOSIS NOTED IN MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 24 MM PROMUS ELEMENT DRUG ELUTING STENT WHICH WAS JAILED BY THE PROMUS ELEMENT STENT PLACED IN RPL BRANCH OF RCA. IN ADDITION, THE 25-30% STENOSIS NOTED IN THE RAMUS WAS TREATED WITH KISSING BALLOON TECHNIQUE, WITH 0% RESIDUAL STENOSIS. THE NEXT DAY, THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893732270 13018308

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention