BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2151745 · Received July 6, 2011

    Report

    Report Number
    2134265-2011-02852
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    January 3, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). 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 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). SAME CASE AS MFR ID#: 2134265-2011-02851, 2134265-2011-02850, 2134265-2011-02853. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, MYOCARDIAL INFARCTION OCCURRED. AT THE TIME OF THE INDEX PROCEDURE, CARDIAC CATHETERIZATION REVEALED 4 TARGET LESIONS. THE FIRST WAS A 75% STENOSED AND 10MM LONG LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THIS WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.0X12MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND WAS AN 80% STENOSED AND 36MM LONG LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THIS WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X38MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE THIRD WAS A 75% STENOSED AND 10MM LONG LESION LOCATED IN THE FIRST OBTUSE MARGINAL (OM1) WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THIS WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.25X12MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE FOURTH WAS AN 80% STENOSED AND 22MM LONG LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THIS WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.25X24MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. IT WAS REPORTED THAT THE PATIENT HAD A 2.5X23MM PROMUS, 3.5X12MM PROMUS, AND AN UNKNOWN SIZE PROMUS IMPLANTED AT THE TIME OF THE INDEX PROCEDURE IN THE DISTAL LAD, PROXIMAL LAD, AND MID LCX. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. (B)(6) 2011: THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO SHORTNESS OF BREATH. ONCE AT THE HOSPITAL, SHE WAS UNABLE TO SPEAK AND WAS CONFUSED AND WAS SUBSEQUENTLY INTUBATED AND PUT ON A VENTILATOR. SHE WAS DIAGNOSED WITH PNEUMONIA AND RESPIRATORY FAILURE. IT WAS NOTED THAT THE PATIENT HAS A LONG STANDING CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH BRONCHIECTASIS AND CENTRAL LOBULAR EMPHYSEMA. THE PATIENT WAS ALSO DIAGNOSED AS HAVING A NON-ST ELEVATION MYOCARDIAL INFARCTION WITH ELEVATED CARDIAC ENZYMES. ECG SHOWED SINUS TACHYCARDIA WITHOUT SYMPTOMS OF ISCHEMIA. MEDICATIONS AT THE TIME OF THE EVENT INCLUDED ASPIRIN 81MG AND PRASUGREL 10MG. CARDIAC CATHETERIZATION REVEALED THAT ALL 7 STENTS IMPLANTED AT THE TIME OF THE INDEX PROCEDURE WERE WIDELY PATENT. THE SECOND DIAGONAL VESSEL WAS SUBTOTALLY OCCLUDED AND AN OBTUSE MARGINAL BRANCH HAD 70% PROXIMAL NARROWING. BOTH WERE PREVIOUSLY TREATED WITH ANGIOPLASTY. IT IS THE OPINION OF THE PHYSICIAN THAT THE CULPRIT VESSEL WAS LIKELY THE DIAGONAL, BUT NOTED THAT A TRANSIENT OCCLUSION OF THE LAD COULD NOT BE EXCLUDED. SHE WAS TREATED WITH PREDNISONE, LEVAQUIN, BETA BLOCKER AND ANTI HEART FAILURE MEDICATIONS. SHE WAS DISCHARGED 5 DAYS LATER IN STABLE CONDITION. THE EVENT IS REPORTED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS NOT RELATED TO THE TAXUS LIBERTE STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893712220 13754041

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R