BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL ELUTING STENT

    MDR report key: 743767 · Received August 2, 2006

    Report

    Report Number
    6000089-2006-01584
    Event Type
    Death
    Date Received
    August 2, 2006
    Date of Event
    January 13, 2006
    Report Date
    July 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY, IT WAS REPORTED THAT 6 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. EIGHT DAYS PRE-PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL; CARDIAC ENZYMES INDICATED AN EVOLVING MYOCARDIAL INFARCTION. THE INDEX PROCEDURE TREATED 1 DE NOVO TARGET LESION. THE TARGET LESION WAS A 3.5MM VESSEL DIAMETER, 9MM LONG, WITH NO CALCIFICATION, AND 90% STENOSIS, IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH AN INVATEC 1.25X20MM BALLOON. THE PHYSICIAN IMPLANTED 1 TAXUS LIBERETE 3.5X12MM DRUG ELUTING STENT (DES) AT 16 ATMS. POST-TREATMENT, THE LESIONS WERE 0% STENOSIS AND TIMI 3 FLOW. THE PATIENT EXPIRED 6 DAYS POST INDEX PROCEDURE, PRIOR TO DISCHARGE. GASTRO INTESTINAL BLEEDING WAS INDICATED AS THE CAUSE OF DEATH. THE PATIENT WAS RECEIVING ASPIRIN AND PLAVIX. THE DEATH, AS INDICATED BY THE PHYSICIAN, WAS UNRELATED TO THE TAXUS LIBERTE STENT. 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 ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.5X12MM 8078002

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death