BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7693392 · Received July 17, 2018

    Report

    Report Number
    2953200-2018-01037
    Event Type
    Death
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 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. DATE OF DEATH UNKNOWN. IMPLANTED DATE UNKNOWN . 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. HOWEVER A PATIENT DEATH WAS REPORTED IN THE POST-OPERATIVE PHASE DUE TO HEMORRHAGIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535663 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death