BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2161673 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02985
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DISSECTION OCCURRED IN THE MID LAD.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 95% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT OF A 3.5 X 12 MM TAXUS LIBERTE STENT. WITH 0% RESIDUAL STENOSIS. DURING THE INDEX PROCEDURE, AFTER PLACEMENT OF THE 3.50 X 12 MM STENT, A GRADE C DISSECTION OCCURRED DISTALLY TO THE STENT AND WAS TREATED WITH A 3.00 X 12 MM TAXUS LIBERTE STENT. THE MID LEFT ANTERIOR DESCENDING ARTERY WAS ALSO TREATED AND WAS 90% STENOSISED, AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTED A 2.75 X 16 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612350 13844999

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 2.75X16MM TAXUS LIBERTE STENT