BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7497718 · Received May 9, 2018

    Report

    Report Number
    2953200-2018-00667
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    December 8, 2017
    Report Date
    May 9, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: AORTIC ANATOMY AND COMPLICATIONS OF THE PROXIMAL SEALING ZONE AFTER ENDOVASCULAR TREATMENT OF THE THORACIC AORTA. AUTHORS: JEREMIE PEIDRO, MOURAD BOUFI, ANDERSON D. LOUNDOU, OLIVIER HARTUNG, BIANCA DONA, FLORENT VERNET, DAVID BENSOUSSAN, AND YVES S. ALIMI, SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTPS://DOI.ORG/10.1016/J.AVSG.2017.09.029. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT AND TALENT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC RUPTURE, AORTIC DISSECTION, ANEURYSM AND OTHER DISEASES (FLOATING THROMBUS, AORTOESOPHAGEAL FISTULA) BETWEEN 2007 AND 2015. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: MALFUNCTION: TYPE IA ENDOLEAK, BIRD BEAK, MALPOSITION, MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341363 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR