BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3781088 · Received April 30, 2014

    Report

    Report Number
    2134265-2014-02317
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    SAME CASE AS MDR ID: 2134265-2014-02315 AND 2134265-2014-02314. IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN AN UNSPECIFIED DATE, A 3.0 X 12 TAXUS LIBERTE STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. IN (B)(6) 2014, THE PATIENT PRESENTED WITH ST ELEVATIONS AND RESTENOSIS. THE PHYSICIAN WENT ON TO BALLOON THE VESSEL. THE FIRST BALLOON USED WAS A 2.50MM X 15MM APEX CATHETER BALLOON WHICH WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED AND ON FIRST INFLATION IT RUPTURED AT 6 ATMOSPHERES (ATMS). THE SECOND BALLOON USED WAS A 2.25MM X 15MM APEX CATHETER BALLOON WHICH WAS ADVANCED TO THE LESION AND ON FIRST INFLATION ALSO RUPTURED AT 6 ATMS. THE 2 DEVICES WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON AND PLACEMENT OF A 3.0X16MM PROMUS PREMIER STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260537 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