BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 4210421 · Received October 29, 2014

    Report

    Report Number
    2953200-2014-02225
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST INDEX, THE PATIENT PRESENTED EMERGENTLY COMPLAINING OF BACK PAIN. A CT SCAN REVEALED A INTRAMURAL HEMATOMA BELOW THE STENT GRAFT. THE FOLLOWING DAY, A 38X34X150 STENT GRAFT WAS PLACED TO RESOLVE THE ISSUE. AN IVUS PERFORMED POST IMPLANT CONFIRMED EXCLUSION OF THE HEMATOMA. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THE HEMATOMA, AND DOES NOT KNOW IF IT WAS RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692483 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04189617

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention