BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2102904 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-01953
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    September 17, 2010
    Report Date
    April 28, 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 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

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE PLACED AN UNSPECIFIED TAXUS LIBERTE STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2010, AT THE 9 MONTH STUDY FOLLOW UP VISIT NO ANGINA WAS DETECTED. IN (B)(6) 2010, AT THE 1 YEAR FOLLOW UP VISIT WITH NO ISCHEMIA, ANGIOGRAPHY REVEALED A 90% RESTENOSED 3.0X10MM LESION IN THE PROXIMAL RCA. TREATMENT CONSISTED OF ANGIOPLASTY AND IMPLANTED A NON BSC 3.0X12MM STENT RESULTING IN 0% RESIDUAL STENOSIS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE INDEX PROCEDURE TREATED THE 90% STENOSED, 3.0X28MM TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. TREATMENT CONSISTED OF PRE-DILATION, THE PLACEMENT OF A 3.0X28MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, AT THE REINTERVENTION PROCEDURE IT WAS NOTED THAT TIMI 3 FLOW WAS MAINTAINED THROUGH OUT THE PROCEDURE. THE PATIENT WAS DISCHARGED THE NEXT DAY. PER THE PHYSICIAN, THE STUDY STENT WAS POSSIBLY RELATED TO THE CORONARY RESTENOSIS EVENT.

    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 UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention