BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL ELUTING STENT

    MDR report key: 761191 · Received September 13, 2006

    Report

    Report Number
    6000089-2006-02010
    Event Type
    Injury
    Date Received
    September 13, 2006
    Date of Event
    June 26, 2006
    Report Date
    August 18, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 # 8062236, 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 140 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A TARGET VESSEL RE-INTERVENTION OCCURRED. THE INDEX PROCEDURE TREATED ONE LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DE NOVO, BIFURCATED LESION WAS 95% STENOSED, 2.7MM IN DIAMETER, 20MM IN LENGTH AND WAS MODERATELY TORTUOUS. THE LESION WAS PRE-DILATED WITH A 2.00X20MM AVION PLUS BALLOON. THE PHYSICIAN FOLLOWED WITH A TAXUS LIBERTE 2.75X28MM STENT DEPLOYED AT 10ATMS. THE LESION WAS NOT POST DILATED; HOWEVER, RESULTS WERE 0% RESIDUAL STENOSIS WITH TIMI-3 FLOW. THE PT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL. ONE HUNDRED AND FORTY DAYS LATER, THE PT UNDERWENT A TARGET VESSEL RE-INTERVENTION OF THE PROXIMAL LAD. THERE WAS 99% STENOSIS ON THE DISTAL EDGE OF THE TAXUS LIBERTE STENT. THE EVENT WAS RESOLVED BY PERFORMING BALLOON ANGIOPLASTY AND PLACEMENT OF A CORDIS CYPHER STENT. THE RESULTS WERE 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE PT WAS ON CLOPIDOGREL AND ASPIRIN AT THE TIME OF THE EVENT. PER THE INVESTIGATOR, THE RELATIONSHIP OF THIS EVENT TO THE DEVICE IS "DEFINITELY" RELATED. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.75 X 28MM 8062236

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R