BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1230212 · Received November 13, 2008

    Report

    Report Number
    2134265-2008-04342
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT EMBOLIZATION OCCURRED. THE PHYSICIAN ATTEMPTED TO PLACE THE 2.50X12MM TAXUS LIBERTE DRUG ELUTING STENT, BUT IT WOULD NOT CROSS THE LESION. DURING WITHDRAWAL, THE STENT DISLODGED WHEN IT REACHED THE DISTAL TIP OF THE CATHETER AND MIGRATED INTO THE GENERAL CIRCULATORY SYSTEM. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. PATIENT STATUS REPORTED AS "NO CONSEQUENCES". ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT PROVIDED.

    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 2.50X12 MM 11630953

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention