BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL- ELUTING CORONARY STENT SYSTEM

    MDR report key: 1345058 · Received March 13, 2009

    Report

    Report Number
    2134265-2009-00952
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    February 25, 2009
    Report Date
    February 27, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #S: 2134265-2009-00955, 213465-2009-00956. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A DISSECTION OCCURRED. THE LESION WAS LOCATED IN A SEVERELY CALCIFIED PROXIMAL AND NARROW LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS NOT PRE-DILATED AND A TAXUS LIBERTE' DRUG ELUTING STENT WAS PLACED IN THE LAD. IT WAS NOTED THAT THE STENT WAS NOT WELL PLACED DUE TO SEVERE CALCIFICATION. THE STENT WAS DEPLOYED AT 9 ATMS FOR 10 SECONDS AND WAS POST DILATED WITH AN UNSPECIFIED BALLOON. WHEN THE STENT WAS DEPLOYED, THE VESSEL DISSECTED BACKWARD INTO THE LEFT MAIN. THE PHYSICIAN EXPERIENCED A "STICKY BALLOON ISSUE". A JL4 GUIDEWIRE WAS USED AND THE UPWARDS TIP WAS PLACED TOWARDS THE ROOF OF THE LEFT MAIN. AS A RESULT, THE GUIDE WAS NOT SEEDED IDEALLY. DUE TO THE SEVERE CALCIFICATION, A SECOND TAXUS LIBERTE STENT WAS PLACED AND IT WAS NOTED THAT THE VESSEL HAD DISSECTED DISTALLY. A THIRD TAXUS LIBERTE STENT WAS PLACED TO COVER THE DISSECTION AND, THE VESSEL DISSECTED FURTHER BOTH PROXIMALLY AND DISTALLY FROM THE ORIGINAL LESION. THE SECOND AND THIRD TAXUS LIBERTE STENTS WERE DEPLOYED AT A SUBOPTIMAL ATM (SIMILAR TO THE FIRST STENT AT 9ATM FOR 10 SECONDS) TO TRY TO MINIMIZE ANY FURTHER DISSECTION AS WELL AS LEFT MAIN DISEASE, THE PATIENT WAS TAKEN TO SURGERY. NO FURTHER PATIENT INJURIES OR COMPLICATIONS OCCURRED. THE PATIENT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL- ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention