BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3000536 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01401
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - 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

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2013 THE SUBJECT UNDERWENT LEFT HEART CATHETERIZATION AND CORONARY ARTERY BYPASS PROCEDURE. CATHETERIZATION REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 40%, MILD AORTIC STENOSIS, AND GRADE-I TRIVIAL AORTIC REGURGITATION. NO FURTHER INTERVENTION WAS PERFORMED.

    Description of Event or Problem · 1

    (B)(4) TRIAL. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, THE PATIENT EXPERIENCED CHEST PAIN. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE 3.0X12MM TAXUS LIBERTE STENT WAS SUCCESSFULLY IMPLANTED. ADDITIONAL PTCA TREATED A LESION IN THE OBTUSE MARGINAL ARTERY. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI II FLOW. PATIENT WAS DISCHARGED ON CLOPIDOGREL. IN (B)(6) 2013, 787 POST INDEX PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102791 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other