BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL ELUTING STENT

    MDR report key: 757759 · Received August 28, 2006

    Report

    Report Number
    6000089-2006-01829
    Event Type
    Injury
    Date Received
    August 28, 2006
    Date of Event
    July 25, 2006
    Report Date
    July 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 # 8663255 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    REGISTRY. IT WAS REPORTED THAT ONE DAY FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION OCCURRED. THE INDEX PROCEDURE IDENTIFIED ONE TARGET LESION. THE DE NOVO LESION WAS 77% STENOSED, LOCATED IN THE 3RD OBTUSE MARGINAL (OM) ARTERY. THE VESSEL WAS 2.65MM IN DIAMETER AND MILDLY TORTUOUS. THE PHYSICIAN DIRECT-STENTED THE LESION WITH A TAXUS LIBERTE 3. 00X12MM STENT AT 14ATMS. THE PHYSICIAN DID NOT POST DILATE; HOWEVER, THE RESULTS WERE TIMI-3 FLOW AND 0% RESIDUAL STENOSIS. IT WAS NOTED THAT THERE WAS FLOW IMPAIRMENT OF A SIDE BRANCH. THE PATIENT WAS GIVEN ASPIRIN AND TICLID FOLLOWING THE PROCEDURE. LATER THAT DAY AFTER THE PROCEDURE, PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED A Q-WAVE MYOCARDIAL INFARCTION (MI). AN ECG WAS PERFORMED AND CARDIAC ENZYMES WERE DRAWN. THE LOCATION OF THE MI WAS INFERIOR AND LATERAL. THE MI WAS RESOLVED BY BALLOON ANGIOPLASTY AND PLACEMENT OF ANOTHER TAXUS LIBERTE STENT. THE PATIENT WAS ON TICLID AND ASPIRIN AT THE TIME OF THE EVENT. THE PATIENT WAS DISCHARGED 10 DAYS LATER ON TICLID AND ASPIRIN. PER THE INVESTIGATOR, THE EVENT IS "UNRELATED" TO THE DEVICE. THIS PRODUCT IS ONLY OUS APPROVED, BUT IS 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 ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.00 X 12MM 8663255

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R