BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2032383 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01059
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    August 27, 2010
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS 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). SAME CASE AS MFR REPORT #: 2134265-2010-04359, 2134265-2010-04360 IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STUDY STENT WAS MALAPPOSED. THE INDEX PROCEDURE TREATED FOUR TARGET LESIONS IN A STAGED INDEX PROCEDURE. THE 1ST LESION WAS A 99% STENOSED, 4.0X20MM TARGET LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). TREATMENT USED A DIRECT STENT TECHNIQUE AND PLACED A 3.5 X 24MM TAXUS LIBERTE STENT AND UTILIZED POST-DILATATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND PRASUGREL. A STAGED PROCEDURE 36 DAYS LATER TREATED THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE SECOND LESION WAS A 75% STENOSED, 4.0X8MM TARGET LESION LOCATED IN THE MID LAD. TREATMENT USED A DIRECT STENT TECHNIQUE AND PLACED A 3.0 X 12MM TAXUS LIBERTE STENT. POST-STENT DEPLOYMENT IVUS WAS USED WHICH NOTED A DISSECTION. THIS WAS TREATED WITH POST-DILATATIONS WITH A NON-COMPLIANT BALLOON AND PLACED A 4.0X12MM TAXUS LIBERTE STENT (THE SAME STENT AS IN LESION 4) RESULTING IN 0% RESIDUAL STENOSIS. THE 3RD LESION WAS A 75% STENOSED, 3.3X8.0MM BIFURCATED TARGET LESION LOCATED IN THE MID LAD. TREATMENT USED A DIRECT STENT TECHNIQUE AND PLACED A 3.0 X 12MM TAXUS LIBERTE STENT AND UTILIZED POST-DILATATION RESULTING IN 0% RESIDUAL STENOSIS. POST STENT DEPLOYMENT IVUS WAS USED WHICH NOTED INCOMPLETE APPOSITION. THIS WAS TREATED WITH POST DILATIONS WITH A NON COMPLIANT BALLOON RESULTING IN 0% RESIDUAL STENOSIS. THE 4TH LESION WAS A 75% STENOSED, 4.3X8.0MM TARGET LESION LOCATED IN THE PROXIMAL LAD ARTERY. TREATMENT USED A DIRECT STENT TECHNIQUE AND PLACED A 4.0 X 12MM TAXUS LIBERTE STENT. POST-STENT DEPLOYMENT IVUS WAS USED WHICH NOTED INCOMPLETE APPOSITION. THIS WAS TREATED WITH POST-DILATATIONS WITH A NON-COMPLIANT BALLOON RESULTING IN 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 LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612300 13067193

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 4X12MM TAXUS LIBERTE| 3.0X12MM TAXUS LIBERTE