BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1964276 · Received January 19, 2011

    Report

    Report Number
    2134265-2010-05944
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER - (B)(6). DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 70% STENOSED TARGET LESION WAS 3.5MM IN DIAMETER AND 12MM LONG. THE LESION WAS A BIFURCATED LESION WITH IN-STENT RESTENOSIS. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT AND A 3.5X24MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 20%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. AT THE 19 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED UNSTABLE ANGINA. CORONARY ANGIOGRAPHY WAS PERFORMED 1 DAY LATER AND REVEALED A TIMI FLOW OF 3 AND 50% IN-STENT RESTENOSIS OF THE TAXUS LIBERTE STENT IN THE PROXIMAL LAD. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED USING AN ANGIOPLASTY BALLOON. RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3 NOTED. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A NEW LESION WAS IDENTIFIED IN THE PROXIMAL CIRCUMFLEX WITH 70% STENOSIS WHICH WAS TREATED WITH STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893624350 13200051

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention