BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3894781 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03612
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RETURNED 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 MDR ID: 2134265-2014-03613. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT CHEST PAIN, MYOCARDIAL INFARCTION (MI) AND STENT THROMBOSIS OCCURRED. ON AN UNSPECIFIED DATE, TWO UNSPECIFIED TAXUS STENTS WERE IMPLANTED IN MID RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2014, THE PATIENT PRESENTED WITH CHEST PAIN RADIATING TOWARDS THE NECK AND JAW AND PATIENT WAS HOSPITALIZED ON THE SAME DAY. ELEVATED CARDIAC ENZYMES VALUES NOTED BUT DID NOT MEET THE PROTOCOL OF MI (CK TOTAL= 661 IU/L; ULN= 140; PEAK CK- MB= 89.8 NG/ML, ULN=5.0 NG/ML; PEAK TROPONIN T =3.33 NG/ML, ULN=0.10 NG/ML). ALSO, ELECTROCARDIOGRAM (ECG) REVEALED INFEROLATERAL ST ELEVATION MI. SUBSEQUENTLY, CARDIAC CATHETERIZATION WAS RECOMMENDED. PATIENT'S CORONARY ANGIOGRAPHY SHOWED 70% STENT THROMBOSIS OF PREVIOUSLY DEPLOYED TAXUS DRUG ELUTING STENTS LOCATED IN MID RCA. THE LESION WAS TREATED WITH BALLOON ANGIOPLASTY AND THROMBECTOMY RESULTING IN 0% RESIDUAL STENOSIS. THREE DAYS POST PROCEDURE, THE EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369908 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R