BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2221022 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03450
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS 2134265-2011-03458. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN. THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2011. LESION 1 WAS A BIFURCATED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY WITH 90% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.0 X 28 MM TAXUS LIBERTE STENT WITH 10% RESIDUAL STENOSIS. A STAGED PROCEDURE WAS COMPLETED 2 DAYS LATER. LESION 2 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.5 X 16 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL 141 DAYS POST INDEX PROCEDURE THE PATIENT DEVELOPED CHEST PAIN AND WAS TREATED WITH MEDICATION.

    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 H7493893616350 13015144

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 3.00X28MM TAXUS LIBERTE STENT