BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 748858 · Received August 11, 2006

    Report

    Report Number
    6000089-2006-01669
    Event Type
    Injury
    Date Received
    August 11, 2006
    Date of Event
    June 23, 2006
    Report Date
    July 20, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 MFG RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 7826375 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. ALL RELEVANT PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT. NO FURTHER CORRECTIVE ACTION IS PLANNED AT THIS TIME. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF COMPLAINT IN ORDER TO ENSURE THAT THERE IS NO COMPROMISE WITH PRODUCT QUALITY. THIS PARTICULAR BATCH NUMBER 8050674 HAS NOT ASSOCIATED COMPLAINTS TO DATE.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT 196 DAYS POST INDEX PROCEDURE, THE PT EXPERIENCED IN-STENT RESTENOSIS AND A SUBSEQUENT TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED A DE NOVO LESION IN THE MID LAD. THE VESSEL WAS 3 MM WIDE, 12 MM LONG, AND 60% STENOSED. THE LESION WAS MILDLY TORTUOUS. THE PHYSICIAN DIRECT STENTED THE LESION WITH A 3 X 20 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 16%. THE PT EXPERIENCED SOME STABLE ANGINA PRIOR TO DISCHARGE. THE PT WAS DISCHARGED 3 DAYS LATER RECEIVING ASPIRIN AND PLAVIX. ON DAY 196, THE PT EXPERIENCED DISTAL AND PROXIMAL EDGE IN-STENT RESTENOSIS. THE LESION WAS RE-STENOSED TO 70%. THE PT WAS TAKING ASPIRIN AND PLAVIX AT THE TIME OF THE EVENT. A MEDTRONIC DE DRIVER STENT WAS PLACED. RESIDUAL STENOSIS POST TREATMENT WAS 0%. IN THE OPINION OF THE PHYSICIAN, THE IN-STENT RESTENOSIS/ TVR WAS DEFINITELY RELATED TO THE TAXUS LIBERTE STENT. THIS PRODUCT IS ONLY OUS APPROVED, BUT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0 X 20 MM 7826375

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R