BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2872986 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07935
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 16, 2012
    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 MANUFACTURER - THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2012-07936, 2134265-2012-07934. (B)(6). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. IN (B)(6) 2009, THREE TAXUS LIBERTE STENTS (2.5 X 32 MM, 3.0 X 32 MM, AND 3.5 X 24 MM) WERE DEPLOYED IN THE RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2009, THE 75% STENOSED, 3.2 X 24 MM LESION BEING TREATED WAS LOCATED IN THE DISTAL RCA. THE LESION WAS PREDILATED AND A 3.0 X 28 MM PROMUS (STUDY) STENT WAS IMPLANTED WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE SITE REPORTED AN EVENT OF ANGINA PECTORIS. THE PATIENT WAS HOSPITALIZED 1224 DAYS POST INDEX PROCEDURE. IN (B)(6) 2012, THE SITE REPORTED THAT PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT RESTENOSIS OF THE LESION PREVIOUSLY TREATED WITH THE THREE TAXUS LITERTE STENTS. THE DISTAL RCA HAD 75% STENOSIS. THE PATIENT WAS TREATED WITH A DRUG-ELUTING STENT REDUCING STENOSIS TO 0%. THE PATIENT WAS DISCHARGED WITHOUT RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632300

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention