BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2981582 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01533
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    March 16, 2012
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. 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)(4). SAME PATIENT AS MDR ID#: 2134265-2011-00559, 2134265-2011-00560, 2134265-2011-00561, 2134265-2011-00562, 2134265-2011-03341, 2134265-2011-03346, 2134265-2011-03347, 2134265-2011-03348, 2134265-2012-06260, 2134265-2012-06261, 2134265-2012-06262, 2134265-2012-06259. SAME CASE AS MDR ID#: 2134265-2013-01107, 2134265-2013-01106, 2134265-2013-01103, 2134265-2013-01178, 2134265-2013-01532. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION OCCURRED. (B)(6) 2011: THE PATIENT PRESENTED WITH SEVERE SUBSTERNAL CHEST PAIN. TROPONIN I LEVELS WERE ELEVATED (PEAK TROPONIN I = 3.17 NG/ML, ULN = 0.05 NG/ML) AND THE PATIENT WAS DIAGNOSED AS HAVING A MYOCARDIAL INFARCTION. ECG SHOWED ST-SEGMENT DEPRESSION IN V5 AND V6 WITH SOME T-WAVE INVERSION IN LEAD 1 AND AVL. CARDIAC CATHETERIZATION REVEALED 75% STENOSIS PROXIMALLY TO THE PREVIOUSLY PLACED STUDY STENTS IN THE LAD WITH DIFFUSE DISEASE THROUGHOUT THE REMAINDER OF THE VESSEL. THERE WAS SUBTOTAL OCCLUSION OF THE POSTEROLATERAL BRANCH AND DIFFUSE DISTAL DISEASE OF THE RIGHT POSTERIOR DESCENDING CORONARY ARTERY. THERE WAS NO EVIDENCE OF IN STENT RESTENOSIS IN THE RCA. THREE DAYS LATER, THE PROXIMAL LAD WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.0 X 12 MM TAXUS STENT RESULTING IN 10% RESIDUAL STENOSIS. AT THIS TIME THE LCX WAS ALSO TREATED WITH PLACEMENT OF A 2.75 X 38 MM AND 3.0 X 16 MM TAXUS STENTS. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS NOT RELATED TO THE TAXUS LIBERTE STENTS. (B)(6) 2012 - THE PATIENT PRESENTED WITH ATYPICAL LEFT RIB PAIN, CLAUDICATION AND DECLINING RENAL FUNCTION DIAGNOSED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND OPEN LABEL PRASUGREL. CARDIAC ENZYMES WERE ELEVATED. THE PATIENT WAS TREATED MEDICALLY AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED THREE DAYS LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83940 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention