BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 8594585 · Received May 9, 2019

    Report

    Report Number
    2953200-2019-00614
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    October 14, 2017
    Report Date
    May 9, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED: COMPARISON OF SUPRA-ARCH IN SITU FENESTRATION AND CHIMNEY TECHNIQUES FOR AORTIC DISSECTION INVOLVING THE LEFT SUBCLAVIAN ARTERY MA XIAOHUI, WEI LI, GUO WEI, LIU XIAOPING, JIA XIN, ZHANG HONGPENG AND WANG LIJUN VASCULAR 2019 27 (2) DOI: HTTPS://DOI.ORG/10.1177/1708538118807013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TALENT STENT GRAFT WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF TYPE B AORTIC DISSECTIONS USING THE CHIMNEY TECHNIQUE TO MAINTAIN LEFT SUBCLAVIAN ARTERY PERFUSION BETWEEN 2006 AND 2015. THE FOLLOWING EVENTS WERE REPORTED: MALFUNCTION: TYPE I ENDOLEAK COMPRESSION OF STENT GRAFT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388722 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR