BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3222465 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04835
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    January 15, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    (B)(4). SAME CASE AS MDR ID: 2134265-2013-04833. IT WAS REPORTED THAT SUBSEQUENT TO A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ST SEGMENT ELEVATION MYOCARDIAL INFARCTION AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2010, A NON-STUDY TAXUS STENT WAS PLACED IN THE RCA (RIGHT CORONARY ARTERY). IN (B)(6) 2012, THE SUBJECT PRESENTED WITH STABLE ANGINA AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED 3 TARGET LESIONS. FIRST WAS A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 99% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 28 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. SECOND WAS A DE NOVO LESION IN THE MID LAD WITH 90% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 32 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THIRD WAS A DE NOVO LESION IN THE DISTAL LAD WITH 80% STENOSIS AND WAS 35 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.3 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 38 MM TAXUS LIBERTE STENT (PER (B)(4), 2.50 X 32 MM TAXUS LIBERTE STENT), WITH 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON (B)(6) 2013, THE SUBJECT PRESENTED WITH CHEST PAIN AND ASSOCIATED WITH SHORTNESS OF BREATH AND WAS HOSPITALIZED ON THE SAME DAY. ECG REVEALED ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. CARDIAC ENZYMES WERE ELEVATED CONSISTENT WITH MYOCARDIAL INFARCTION. AT THE TIME OF THE EVENT, THE SUBJECT WAS TAKING ASPIRIN. THE SUBJECT WAS DIAGNOSED WITH ST ELEVATION MYOCARDIAL INFARCTION AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A 95% IN-STENT RESTENOSIS AND SUBTOTAL OCCLUSION IN PROXIMAL PORTION OF THE LAD. IT WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.00 X 15 MM NON-BSC STENT, WITH 0% RESIDUAL STENOSIS. IN ADDITION, A NON-TARGET LESION, TOTALLY OCCLUDED 2ND OBTUSE MARGINAL AND WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.75 X 15 MM NON-BSC STENT, WITH 0% RESIDUAL STENOSIS. DURING THE COURSE OF EVENT, THE SUBJECT WAS TREATED MEDICALLY. TWO DAYS AFTER, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON SAME DAY ON ASPIRIN AND EFFIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322102 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R