BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 9631559 · Received January 27, 2020

    Report

    Report Number
    9612164-2020-00419
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    September 7, 2011
    Report Date
    January 27, 2020
    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

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED: ENDOVASCULAR STENT-GRAFT TREATMENT FOR STANFORD TYPE A AORTIC DISSECTION HTTPS://DOI.ORG/10.1016/J.EJVS.2011.08.015 C. YE, G. CHANG, S. LI, Z. HU, C. YAO, W. CHEN, X. LI AND S. WANG EUR J VASC ENDOVASC SURG 2011 VOLUME 42 ISSUE6. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC TALENT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE THORACIC ENDOVASCULAR REPAIR OF TYPE A AORTIC DISSECTIONS. THE FOLLOWING EVENTS WERE REPORTED: MALFUNCTION: TYPE IA ENDOLEAK TYPE IB ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94050 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR