BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1912891 · Received December 2, 2010

    Report

    Report Number
    2134265-2010-05258
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW FOR THE REPORTED BATCH CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4)

    Description of Event or Problem · 1

    (B)(4) IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 75% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT IMPLANTATION OF A 3MM X 12MM TAXUS LIBERTE STENT. POST-DILATATION WAS PERFORMED WITH 9% RESIDUAL STENOSIS. A DISSECTION OCCURRED AND A 3MM X 8MM TAXUS LIBERTE STENT WAS USED TO TREAT THE DISSECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 H7493893712300 13424072

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention