BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1905116 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05087
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 2.5-2.75MM WIDE, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS, OCCLUDED RIGHT CORONARY ARTERY (RCA). AFTER THE LESION WAS PREDILATED WITH A 2.0X12MM APEX BALLOON, A 2.5X32MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED IN THE MID RCA. NEXT, A 2.5X24MM TAXUS LIBERTE SDS WAS ADVANCED PROXIMAL TO THE FIRST STENT AND DEPLOYED SUCCESSFULLY. LASTLY, THE PHYSICIAN TRIED TO ADVANCE A 2.25X12MM TAXUS LIBERTE ATOM SDS THROUGH THE TWO JUST PLACED STENTS BUT THE SDS WOULD NOT CROSS. UPON REMOVAL IT WAS NOTED THAT THE STENT DISLODGED AND WAS FOUND OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 2.25X13MM NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    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 - MAPLE GROVE H7493893612220 13655638

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 2.0X12 APEX| 2.5X24 TAXUS LIBERTE STENT| 2.5X32 TAXUS LIBERTE STENT