BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STE

    MDR report key: 3241088 · Received September 1, 2006

    Report

    Report Number
    6000089-2006-01898
    Event Type
    Injury
    Date Received
    September 1, 2006
    Date of Event
    February 19, 2006
    Report Date
    August 3, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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

    (B)(4). IT WAS REPORTED THAT 3 DAYS POST INDEX PROCEDURE, THE PT EXPERIENCED A MYOCARDIAL INFARCTION (MI). THE INDEX PROCEDURE TREATED A BIFURCATED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VESSEL WAS 3 MM WIDE, 13 MM LONG, AND 70% STENOSED. THERE WAS MODERATE CALCIFICATION AND MILD TORTUOSITY. THE PHYSICIAN DIRECT STENTED THE LESION WITH 2.75 X 16 MM TAXUS LIBERTE STENT. AFTER POST DILATATION,, RESIDUAL STENOSIS WAS 0%. THE PT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. ON DAY 3, THE PT HAD AN MRI. ECG CONFIRMED A NON Q-WAVE MI, AND TROPONIN LAB WAS CONSISTENT WITH MI. THE PT UNDERWENT AN INTERVENTION TO A NON-TARGET VESSEL, AND THE MI RESOLVED. THE PT WAS TAKING ASPIRIN AND PLAVIX AT THE TIME OF THE EVENT. IN THE OPINION OF THE PHYSICIAN, THERE IS A POSSIBLE RELATIONSHIP OF TVR 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 STE DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.75 X 16 MM 8120427

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R