BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1950021 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05736
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: OVER 18 YEARS. DEVICE IS 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 REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2010, THE 75% STENOSED, 3.0MM IN DIAMETER, LESION BEING TREATED WAS LOCATED IN THE 'S' SHAPED, SEVERELY TORTUOUS, SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 3.00X16MM TAXUS LIBERTE STENT WAS IMPLANTED. IN (B)(6) 2010, IN-STENT RESTENOSIS WAS IDENTIFIED. THE PHYSICIAN ATTEMPTED TO POSITION A 3.00X10MM FLEXTOME CUTTING BALLOON, BUT WAS UNABLE TO CROSS THE LESION. A PT2 GUIDE WIRE WAS INSERTED, FOR A PARALLEL WIRE TECHNIQUE, AND THE FLEXTOME WAS ABLE TO CROSS THE LESION. HOWEVER, WHEN INFLATED TO 4 ATMS THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY, PERFORMED WITH A 3.0X15MM NON-BSC BALLOON. PATIENT'S STATUS IS GOOD.

    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 - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention