BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3800939 · Received May 8, 2014

    Report

    Report Number
    2953200-2014-00944
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 CHRONIC TYPE B DISSECTION. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS NOT REPORTED. THE PATIENT HAD A TYPE II ENDOLEAK IN THE SUBCLAVIAN THAT WAS EMBOLIZED POST INDEX PROCEDURE. CURRENTLY IT WAS REPORTED THAT THE THORACIC AORTA WALLS ARE VERY THIN AND FRAIL. THE PATIENT HAS A CONNECTIVE TISSUE DISORDER THAT CAUSES THEIR AORTA TO BE FRIABLE. A RECENT CT REVEALED A PERFORATION OF THE AORTA WALL AT THE LEVEL OF THE APEX OF ONE OF THE PROXIMAL METAL STENT STRUTS AND A TYPE A DISSECTION. THE PHYSICIAN ELECTED TO PERFORM AN OPEN REPAIR WITH A REVERSE FROZEN ELEPHANT TRUNK ATTACHING THE ELEPHANT TRUNK TO THE EXISTING STENT GRAFT. THE AORTIC PERFORATION WAS SUCCESSFULLY COVERED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277939 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01094866

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention