BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2024106 · Received March 18, 2011

    Report

    Report Number
    2134265-2011-00778
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    SAME CASE AS MDR# 2134265-2011-00779. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OUTSIDE THE PATIENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE OBTUSE MARGINAL (OM). A PREVIOUS IMPLANTED UNKNOWN TAXUS STENT WAS LOCATED IN THE OM. THE PHYSICIAN HAD TO DELIVER THE DEVICES THROUGH A SAPHENOUS VEIN GRAFT (SVG) TO THE OM. THE LESION WAS PREDILATED WITH A 2.0X12MM MAVERICK BALLOON. THE PHYSICIAN ATTEMPTED TO PLACE THE 2.25X16MM TAXUS LIBERTE ATOM STENT, BUT WAS UNABLE TO REACH THE LESION SITE. THE STENT DELIVERY SYSTEM (SDS) BECAME CAUGHT ON THE GUIDE DURING REMOVAL. WHEN ENTIRE SYSTEM WAS REMOVED, THE STENT CAME OFF THE SDS BALLOON OUTSIDE THE PATIENT. THE PHYSICIAN FOUND THE STENT TO BE FLARED ON THE PROXIMAL END. THEN THE PHYSICIAN ATTEMPTED TO PLACE THE 2.25X12MM TAXUS LIBERTE ATOM STENT, BUT WAS UNABLE TO REACH THE LESION SITE. THE STENT DELIVERY SYSTEM (SDS) BECAME CAUGHT ON THE GUIDE DURING REMOVAL. WHEN ENTIRE SYSTEM WAS REMOVED, THE STENT CAME OFF THE SDS BALLOON OUTSIDE THE PATIENT. THE PHYSICIAN FOUND THE STENT TO BE FLARED ON THE PROXIMAL END. THE SAME GUIDE CATHETER AND SAME GUIDE WIRE WERE USED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 H7493893616220 13905828

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDTRONIC LAUNCHER GUIDE CATHETER| GUIDE AL1 GUIDE CATHETER| BMW LATER GUIDE WIRE| 2.0X12 MAVERICK BALLOON| BHW GUIDE WIRE