BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT

    MDR report key: 4103037 · Received September 19, 2014

    Report

    Report Number
    2953200-2014-01871
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NECK DIAMETER GREATER THAN 32MM.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN BELIEVES THE CAUSE OF THE ENDOLEAK WAS RELATED TO DISEASE PROGRESSION DUE TO NECK DILATATION. THE PHYSICIAN PERFORMED A SECONDARY INTERVENTION. A VALIANT STENT GRAFT WAS IMPLANTED HOWEVER, THE PROXIMAL TYPE I ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN PLANS ON MONITORING THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582571 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04106209

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR