BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2993000 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01245
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED. 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) STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI). THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH 75% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING A 3.00 X 12 MM TAXUS LIBERTE STENT, WITH 9% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST PAIN IN THE LEFT CHEST WALL ASSOCIATED WITH VIGOROUS COUGHING AND WAS HOSPITALIZED. ADMISSION ECG REVEALED NONSPECIFIC ST DEPRESSIONS WITH NORMAL SINUS RHYTHM. CARDIAC ENZYMES WERE ELEVATED AND THE PATIENT WAS DIAGNOSED WITH A MI AND CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND NOT ON A STUDY DRUG WHICH WAS LAST TAKEN IN (B)(6) 2012. THE PATIENT WAS TAKING STUDY DRUG AT THE TIME OF THE EVENT, WHICH WAS ADVISED TO BE DISCONTINUED. NO INTERVENTION WAS PERFORMED AND THE SUBJECT WAS MANAGED MEDICALLY FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97891 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893712300 13355385

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention