BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL ELUTING STENT

    MDR report key: 762969 · Received September 18, 2006

    Report

    Report Number
    6000089-2006-02028
    Event Type
    Injury
    Date Received
    September 18, 2006
    Date of Event
    July 5, 2006
    Report Date
    August 21, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    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 # 8193548 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    CLINICAL REGISTRY. IT WAS REPORTED 132 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE; A TAGET VESSEL RE-INTERVENTION WAS PERFORMED. THE INDEX PROCEDURE TREATED TWO LESIONS IN THE RIGHT CORONARY ARTERY (RCA). TARGET LESION 1 WAS LOCATED IN THE MID RCA. THE DE NOVO LESION WAS 88% STENOSED, 3MM IN DIAMETER, 28MM IN LENGTH, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE LESION WAS PRE-DILATED WITH A 2.50X20MM CORDYNAMIC BALLOON. THE PHYSICIAN DEPLOYED A TAXUS LIBERTE 3.00X32MM STENT AT 16ATMS. THE STENT WAS NOT POST DILATED AND RESULTS WERE 6% RESIDUAL STENOSIS AND TIMI-3 FLOW. TARGET LESION 2 WAS LOCATED IN THE PROXIMAL RCA. THE OSTIAL, DE NOVO LESION WAS 75% STENOSED, 3 .5MM IN DIAMETER, AND 7MM LONG. THE PHYSICIAN DIRECT-STENTED THE LESION WITH A TAXUS LIBERTE 3.50X8MM STENT AT 16ATMS. THE RESULTS WERE 4% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON 100MG OF ASPIRIN AND 75MG OF CLOPIDOGEL. AS OF 132 DAYS FOLLOWING THE INDEX PROCEDURE, THE PATIENT RETURNED TO THE CATH LAB. AN ANGIOGRAM CONFIRMED THERE WAS RESTENOSIS OF THE 3.00X32MM TAXUS LIBERTE STENT. THE RESTENOSIS WAS CHARACTERIZED AS 78% PROXIMAL EDGE STENOSIS. THE EVENT WAS RESOLVED BY PERFORMING BALLOON ANGIOPLASTY AND PLACEMENT OF A CORDIS CYPHER STENT. THE RESULTS OF TREATMENT WERE 7% RESIDUAL STENOSIS WITH TIMI-3 FLOW. THE PATIENT WAS TAKING ASPIRIN AND CLOPIDOGREL AT THE TIME OF THE EVENT. PER THE INVESTIGATOR, THE EVENT IS "DEFINITELY: RELATED TO 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. 3. 00 X 32MM 8193548

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R