BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7693414 · Received July 17, 2018

    Report

    Report Number
    2953200-2018-01038
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    March 7, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ENDOVASCULAR REPAIR OF BLUNT THORACIC AORTIC TRAUMA: IS POSTIMPLANT HYPERTENSION AN INCIDENTAL FINDING - KONSTANTINOS TIGKIROPOULOS, FRAGISKA SIGALA, DIAMANTIS I. TSILIMIGRAS ,2DEMETRIOS MORIS, KONSTANTINOS FILIS, NIKOLAOS MELAS, DIMITRIOS KARAMANOS, CHRISTOS KONTOGIANNIS, IOANNIS LAZARIDIS, AND NIKOLAOS SARATZIS, THESSALONIKI AND ATHENS, GREECE, AND DURHAM, NORTH CAROLINA ANN VASC SURG 2018; 50: 160E166 DOI.ORG/10.1016/J.AVSG.2018.01.100. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN 23 PATIENTS FOR THE ENDOVASCULAR TREATMENT OF BLUNT THORACIC AORTIC TRAUMA BETWEEN (B)(6) 2005 AND (B)(6) 2016. THE FOLLOWING DEVICE MALFUNCTION WAS OBSERVED; PROXIMAL COLLAPSE OF ENDOGRAFT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535319 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1