BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2962002 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00611
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    May 11, 2010
    Report Date
    January 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME CASE AS MDR ID#: 2134265-2013-00612. SAME PATIENT AS MDR ID#: 2134265-2010-00977. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA PECTORIS. IN (B)(6) 2009, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT'S QUALIFYING CONDITION AS STABLE ANGINA (CCS CLASS I). THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH 100% STENOSIS AND WAS 72.0MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF TWO TAXUS LIBERTE STENTS OF SIZE 2.50X32MM AND 2.75X32MM WITHOUT GAP, RESULTING IN 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. TIMI FLOW GRADE IMPROVED FROM 0 TO 3. A 3.5X8MM NON-BSC STENT WAS ALSO PLACED IN THE MID RCA. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS ON CLOPIDOGREL SULFATE, CILOSTAZOL, ASPIRIN AND WARFARIN POTASSIUM. IN (B)(6) 2010, THE PATIENT PRESENTED WITH ANGINA PECTORIS. IN (B)(6) 2010, THE PATIENT PRESENTED WITH ISCHEMIC SYMPTOM (STABLE ANGINA). 90% RESTENOSIS OF THE NON-BSC STENT WAS IDENTIFIED IN THE MID RCA. THIS WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA) AND PLACEMENT OF A PROMUS STENT, RESULTING IN 0% RESIDUAL STENOSIS AND TIMI FLOW GRADE REMAINED 3. THE ANGINA PECTORIS SUBSIDED AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65489 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632250

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention