BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3844196 · Received June 2, 2014

    Report

    Report Number
    2953200-2014-01105
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. CURRENTLY, THE ANEURYSM MEASURES 8.5 CM IN DIAMETER. IT WAS REPORTED THAT VALIANT STENT GRAFT HAD MIGRATED PROXIMALLY DUE TO ANEURYSM EXPANSION. A DISTAL TYPE I ENDOLEAK WAS ALSO NOTED. THE PHYSICIAN DECIDED TO INTERVENE AND IMPLANT A VALIANT STENT GRAFT WHICH SEALED THE ANEURYSM, RESOLVING THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322430 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01111990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention