BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904163 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-04991
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT 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 MFR REPORT #: 2134265-2010-04992. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT MOVED ON A BALLOON. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED ECCENTRIC DE NOVO LESION MEASURING 2.5MM IN DIAMETER WAS LOCATED AT THE BIFURCATION OF A CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A DIAGONAL ARTERY, EXTENDING 8MM INTO THE DIAGONAL ARTERY AND 10MM INTO THE LAD. THE LESION WAS PREDILATED WITH A 2.5X12MM APEX BALLOON WHICH REDUCED THE STENOSIS TO 20%. A 2.5X16MM TAXUS LIBERTE' STENT AND A 2.5X12MM TAXUS LIBERTE' STENT WERE ADVANCED TO THE LESION, WITH ONE STENT ADVANCED INTO THE DIAGONAL ARTERY AND THE OTHER STENT ADVANCED INTO THE LAD. BOTH STENTS WERE INFLATED IN A KISSING TECHNIQUE TO 4-5 ATMS. THE PHYSICIAN THOUGHT THAT THE STENTS HAD BEEN DEPLOYED, AND AS THE DEVICES WERE BEING REMOVED FROM THE PATIENT, RESISTANCE WAS FELT. UPON EXAMINATION OF THE DEVICES OUTSIDE THE PATIENT, IT WAS NOTED THAT THE STENTS DID NOT DEPLOY; HOWEVER, THEY HAD BOTH MOVED ON THE BALLOON. THE PROCEDURE WAS COMPLETED BY PLACING A 2.75X20MM TAXUS LIBERTE' STENT IN THE LESION IN THE LAD. AN ADDITIONAL, MORE PROXIMAL LESION WAS THEN TREATED BY DEPLOYING THREE TAXUS LIBERTE' STENTS. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS 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 H7493893616250

    Patients

    Seq Age Sex Outcome Treatment
    1 2.5X12MM APEX BALLOON| 2.5X12MM TAXUS LIBERTE' STENT