BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1970062 · Received January 25, 2011

    Report

    Report Number
    2134265-2011-00034
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    May 11, 2010
    Report Date
    January 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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

    SAME CASE AS 2134265-2010-04947. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE RESTENOSIS OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN A 3.00 MM DIAMETER MID RIGHT CORONARY ARTERY. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING TWO (3.00X28MM AND 3.50X28MM) TAXUS LIBERTE STENTS WITHOUT GAP, AND POST-DILATATION. RESIDUAL STENOSIS WAS 0%. TIMI FLOW IMPROVED FROM 1 TO 3. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS TWO DAYS LATER ON ASPIRIN AND CLOPIDOGREL BISULFATE. ON THE 308 DAYS POST-INDEX PROCEDURE, RESTENOSIS WAS CONFIRMED. THE PATIENT DID NOT HAVE ISCHEMIC SYMPTOMS. THE LESION LOCATED IN PROXIMAL RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM, A LENGTH OF 8.0 MM, AND VISUALLY 75% STENOSIS WAS TREATED WITH A CUTTING BALLOON. RESIDUAL STENOSIS BECAME 10% AND TIMI-3 FLOW KEPT THROUGH THE PROCEDURE. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    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 - GALWAY H7493893612350

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 3.00X28MM TAXUS LIBERTE STENT