BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STE

    MDR report key: 764020 · Received September 18, 2006

    Report

    Report Number
    6000089-2006-02036
    Event Type
    Injury
    Date Received
    September 18, 2006
    Date of Event
    April 20, 2006
    Report Date
    August 24, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8081887 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED 93 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED A DE NOVO LESION IN THE DISTAL CIRCUMCLEX (CX). THE LESION WAS 2.5 MM WIDE, 22 MM LONG, AND 80% STENOSED. THERE WAS SEVERE CALCIFICATION. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING A 2.5 X 24 MM TAXUS LIBERTE STENT. THE PATIENT RECEIVED AN UNSPECIFIED GPIIB/IIIA INHIBITOR DURING THE PROCEDURE. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 3 DAYS LATER ON ASPIRIN AND PLAVIX. ON DAY 93, THE PATIENT EXPERIENCED A TVR TO THE PROXIMAL CX. THE LESION WAS 95% STENOSED. BALLOON ANGIOPLASTY WAS PERFORMED ON THE LESION AND ANOTHER TAXUS LIBERTE STENT WAS PLACED. IT IS UNKNOWN IF THE STENT OVERLAPPED THE PREVIOUSLY PLACED STENT IN THE DISTAL CX. RESIDUAL STENOSIS WAS 0% POST PROCEDURE. THE PATIENT WAS TAKING ASPIRIN AND PLAVIX AT THE TIME OF THE EVENT. IN THE OPINION OF THE PHYSICIAN, THERE IS NO RELATIONSHIP BETWEEN THE TVR IN THE PROXIMAL CX AND THE TAXUS LIBERTE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STE DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORPORATION 2.5 X 24 MM 8081887

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R