BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3971788 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04519
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    May 20, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT CHEST PAIN, DYSPNEA, WEAKNESS, MYOCARDIAL INFARCTION (MI) AND IN-STENT RESTENOSIS (ISR) OCCURRED. ON (B)(6) 2010, THE PATIENT PRESENTED WITH SHARP RETROSTERNAL CHEST PAIN ASSOCIATED WITH DIZZINESS, NAUSEA, NEAR- SYNCOPE AND DYSPNEA. THE PATIENT WAS DIAGNOSED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS AN ISR LESION ON UNSPECIFIED STENT LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 95% STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF A 4.00 X 12MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THREE DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON (B)(6) 2014, THE PATIENT PRESENTED TO AN OUTSIDE FACILITY WITH SUBSTERNAL CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH AND GENERALIZED WEAKNESS. ELECTROCARDIOGRAM WAS PERFORMED AND REVEALED SINUS RHYTHM WITH Q WAVES ANTERIORLY, MILD ST ELEVATION AND NO ACUTE ST DEPRESSIONS. TROPONIN LEVELS WERE NOTED TO BE ELEVATED AND CARDIAC ENZYMES WERE NOT CONSISTENT WITH THE PROTOCOL DEFINITION OF MI. THE PATIENT WAS DIAGNOSED WITH NON-Q WAVE AND NON STEMI. ALSO, THE PATIENT WAS NOTED TO HAVE RESPIRATORY DISTRESS AND DIAGNOSED WITH COMMUNITY ACQUIRED PNEUMONIA AND WAS SEEN BY PULMONOLOGY SERVICE. THE PATIENT WAS TRANSFERRED TO THE ENROLLING SITE AND WAS REFERRED FOR EMERGENT CARDIAC CATHETERIZATION. AT THE TIME OF EVENT, THE PATIENT WAS NOT ON DUAL ANTIPLATELET THERAPY, ASPIRIN WAS LAST TAKEN ON 2013. THE STUDY DRUG WAS LAST TAKEN ON 2011 AND OTHER ANTIPLATELET MEDICATION WAS LAST TAKEN ON (B)(6) 2011. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 70% PROXIMAL EDGE RESTENOSIS OF THE STUDY STENT IN THE PROXIMAL LAD. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT WITH A 3.50 X 9MM NON-BSC DRUG-ELUTING STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. IN ADDITION, THE PATIENT DEVELOPED ULCERS ON THE LIPS CONSISTENT WITH HERPES LABIALIS. THE PATIENT WAS SEEN BY INFECTIOUS DISEASE SERVICE AND ANTIVIRAL THERAPY WAS PRESCRIBED. SIX DAYS POST PROCEDURE, THE EVENTS WERE CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448949 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893712400 13368079

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R