BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4156455 · Received October 9, 2014

    Report

    Report Number
    2953200-2014-02023
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    October 17, 2013
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. SECONDARY AORTIC DISSECTION AFTER ENDOLUMINAL TREATMENT OF AN INTRAMURAL HEMATOMA OF THE THORACOABDOMINAL AORTA: ENDOVASCULAR EXTENSION WITH TWO STENT GRAFTS AND SCARCE DISTAL LANDING PETER I. KALMAR, PETER OBERWALDER, PETER SCHEDLBAUER, JÜRGEN STEINER, AND RUPERT H. (B)(6). THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: POST-OPERATIVE DISSECTION NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. THE MANAGEMENT OF DISSECTIONS OF THE THORACOABDOMINAL AORTA WITH A MARGINAL DISTAL LANDING ZONE REMAINS CONTROVERSIAL. SURGICAL RECONSTRUCTION PROVIDES A SAFE WAY TO AVOID THE RISK OF VISCERAL BRANCH OCCLUSION. IN SOME CASES, HOWEVER, ENDOVASCULAR THERAPY SHOULD BE CONSIDERED WHEN A SCARCE DISTAL LANDING IS POSSIBLE. HEREIN, WE REPORT A CASE IN WHICH A THORACIC AORTIC STENT GRAFT WAS DISTALLY EXTENDED IN ORDER TO SUCCESSFULLY TREAT A SECONDARY DISSECTION CLOSE TO THE CELIAC TRUNK¿S ORIGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635158 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention