BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3043517 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02081
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    June 8, 2012
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. SAME PATIENT AS MDR ID#: 2134265-2010-04770, 2134265-2010-03759, 2134265-2010-03921, 2134265-2010-03922, 2134265-2013-00556, 2134265-2013-00557, 2134265-2013-02066, 2134265-2013-02067, 2134265-2013-02077, 2134265-2013-02076. SAME CASE AS MDR ID#: 2134265-2013-02080. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASS 2) AND SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (PROX LCX) EXTENDING TO 1ST OBTUSE MARGINAL BRANCH (OM1) WITH 90% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF TWO OVERLAPPING TAXUS LIBERTE STENTS, WITH ONE 3.0X16MM STENT PLACED PROXIMALLY AND ANOTHER 2.5X32MM STENT PLACED DISTALLY. INTRAVASCULAR ULTRASOUND REVEALED INCOMPLETE APPOSITION AND THE STENTS WERE POST-DILATED WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(4) 2012, THE PATIENT PRESENTED FOR EVALUATION OF RENAL TRANSPLANT AND KNEE SURGERY. NUCLEAR SCAN REVEALED STRESS INDUCED ISCHEMIA. IN (B)(6) 2012, THE PATIENT WAS HOSPITALIZED AND WAS REFERRED FOR CARDIAC CATHETERIZATION. 80% IN-STENT RESTENOSIS WAS NOTED IN THE PROXIMAL PORTION OF OM1, WHICH WAS TREATED WITH CUTTING BALLOON DILATATION AND PLACEMENT OF A 3.00X12MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. IN ADDITION, THE STENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WAS TREATED WITH CUTTING BALLOON DILATION AND PLACEMENT OF A 3.00X18MM NON-BSC DRUG ELUTING STENT. THE OCCLUDED DISTAL LAD WAS DECIDED TO BE MANAGED MEDICALLY. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND PRASUGREL. THE STUDY DRUG WAS NEVER TAKEN DURING THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147758 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893616300 12894802

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R