BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3180063 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04287
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBSEQUENT TO A CORONARY STENTING TREATMENT PROCEDURE A LATE STENT THROMBOSIS OCCURRED. IN (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH A 2.75 X 24MM TAXUS LIBERTE STENT DELIVERY SYSTEM. UPON FOLLOW-UP CORONARY ANGIOGRAPHY ON (B)(6) 2013 IT REVEALED A LATE STENT THROMBOSIS AND THE PHYSICIAN DECIDED TO UNDERGO PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAPHY PROCEDURE AND USED A 2.75 X 38 MM PROMUS ELEMENT STENT DELIVERY SYSTEM TO TREAT THE LESION. THE EVENT WAS CONSIDERED AS RESOLVED. NO PATIENT COMPLICATION WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280758 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894024270 15413302

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention