BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2973085 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00934
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    October 2, 2012
    Report Date
    January 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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

    (B)(4). IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, PATIENT EXPERIENCED CARDIAC CHEST PAIN AND TARGET VESSEL RE-OCCLUSION. THE SUBJECT PRESENTED WITH DISCOMFORT IN THE RIGHT UPPER CHEST WHICH RADIATED TO RIGHT SHOULDER AND DOWN TO RIGHT ARM; CARDIAC ENZYMES WERE DRAWN AND WAS ABNORMAL. SUBJECT WAS DIAGNOSED WITH NON ST ELEVATION MYOCARDIAL INFARCTION (KILLIP CLASSIFICATION: THE 3.5 X 25 MM, 100% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE LESION WAS PRE-DILATED AND THE 3.5 X 32 MM TAXUS LIBERTE STENT WAS IMPLANTED, POST-DILATION RESULTED IN 0% RESIDUAL STENOSIS. IN (B)(6) 2012, PATIENT WAS HOSPITALIZED DUE TO WORSENING CHEST PAIN. THE OSTIUM OF THE LAD WAS TOTALLY OCCLUDED. PATIENT UNDERWENT PCI BUT THE TREATMENT WAS ABORTED AS MULTIPLE WIRES USED WERE UNABLE TO ADVANCE THROUGH THE OSTIUM OF THE LAD; HENCE THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT SURGERY, LIMA TO LAD, SVG TO PD AND PL. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76431 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893632350 13646022

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other