BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3162743 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-03812
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION 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) CLINICAL TRIAL. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES. THE PATIENT PRESENTED WITH CLASS 1, NON-Q WAVE NON-ST ELEVATION MYOCARDIAL INFARCTION (B)(6) 2011 AND CARDIAC CATHETERIZATION WAS PERFORMED REVEALING 1 TARGET LESION. THE DE NOVO AND 100% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.00MM AND A LESION LENGTH OF 26MM. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON AND 3.00X28MM TAXUS LIBERTE STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. FOLLOWING STUDY STENT PLACEMENT, SLOW FLOW OCCURRED WHICH WAS TREATED WITH MULTIPLE INJECTIONS OF FRESH BLOOD AND 500 MCG OF ADENOSINE OVER THE COURSE OF 15-20 MINUTES UNTIL FLOW WAS RESTORED. IN ADDITION, A NON-TARGET LESION LOCATED IN THE MID RIGHT CORONARY ARTERY WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00X15MM PROMUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. TWO DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013 THE PATIENT PRESENT WITH SHORTNESS OF BREATH. ECG REVEALED NORMAL SINUS RHYTHM AND LEFT AXIS DEVIATION AND TROPONIN WAS FOUND TO BE ELEVATED. THE SUBJECT WAS DIAGNOSED WITH RESPIRATORY FAILURE, HYPERKALEMIA, AND NON Q-WAVE NON-ST ELEVATION MYOCARDIAL INFARCTION AND WAS HOSPITALIZED ON THE SAME DAY. RADIOLOGICAL EXAMINATION OF THE CHEST SHOWED ¿MARKEDLY PROGRESSED PATCHY BILATERAL LUNG AIRSPACE NODULAR DENSITIES¿. THE PATIENT WAS NOT A CANDIDATE FOR AGGRESSIVE TREATMENT AND HENCE, AGREED TO QUIT AGGRESSIVE TREATMENT AND PROCEED WITH PALLIATIVE CARE INSTEAD. CHEST X-RAY REVEALED VERY EXTENSIVE ¿LARGE CANNONBALLS IN THE LUNGS¿. THE PATIENT HAD BEEN ON RADIATION TREATMENT FOR ENDOMETRIAL CANCER. THE PATIENT WAS PLACED ON BIPAP AND OXYGEN. AFTER INITIAL RESPONSE, THE PATIENT DETERIORATED AND HAD WORSENING HYPERCAPNIA AND HYPOXEMIA. THE FOLLOWING DAY RADIOLOGICAL EXAMINATION OF THE CHEST SHOWED ¿UNCHANGED CARDIOMEGALY, MODERATE LEFT LUNG BASE CONSOLIDATION/ EFFUSION AND INNUMERABLE HAZY LUNG NODULARITY.¿ THE FOLLOWING DAY RADIOLOGICAL EXAMINATION OF THE CHEST SHOWED ¿UNCHANGED CARDIOMEGALY WITH A TRACH, MODERATE LEFT LUNG BASE CONSOLIDATION/ EFFUSION AND INNUMERABLE HAZY LUNG NODULES UNIMPROVED. NO NEW LUNG FINDINGS AND NO PNEUMOTHORAX.¿ THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF RBC. TWO DAYS LATER, SPUTUM CULTURES OF THE SUBJECT SHOWED MRSA. THE SUBJECT WAS TREATED WITH BACTRIM. THE FOLLOWING DAY THE PATIENT'S CONDITION CONTINUED TO DETERIORATE FURTHER AND THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS RESPIRATORY FAILURE. THE PHYSICIAN ASSESSED THE DEATH AS UNRELATED TO THE STUDY DEVICE. AT THE TIME OF THE EVENT, THE PATIENT WAS NOT ON DUAL ANTIPLATELET MEDICATION AND DID NOT TAKE ANY OTHER ANTIPLATELET MEDICATION DURING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262685 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893728300 13509457

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other