BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 4975761 · Received August 5, 2015

    Report

    Report Number
    2953200-2015-01280
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A HYPERTENSIVE EPISODE (240/160) AND ABDOMINAL PAIN. A CT OF THE CHEST AND ABDOMEN DISCOVERED THE ANEURYSM IS 7.8 CM IN DIAMETER DUE TO A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN TOOK THE PATIENT TO THE OR AND IMPLANTED A VALIANT 38X38X200 UP TO THE SUBCLAVIAN ARTERY. THE INTERVENTION WAS SUCCESSFUL AND THE ENDOLEAK HAS RESOLVED. THE PHYSICIAN STATED THAT THE ENDOLEAK WAS CAUSED BY A COMBINATION OF AORTIC REMODELING AND UNCONTROLLED HYPERTENSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514706 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3838C150TU

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention