BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT NAVION

    MDR report key: 9720292 · Received February 18, 2020

    Report

    Report Number
    9612164-2020-00772
    Event Type
    Death
    Date Received
    February 18, 2020
    Report Date
    March 4, 2020
    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

    ADDITIONAL INFORMATION:IT WAS REPORTED THAT AN ADDITIONAL VALIANT NAVION WAS IMPLANTED DURING THE INDEX PROCEDURE. THE DATE OF DEATH IS UNKNOWN. THE CAUSE OF DEATH ACCORDING TO THE PHYSICIAN IS THE CEREBRAL ACCIDENT. OTHER RELEVANT DEVICES ARE: VNMF4040C183TU; S/N: (B)(4); USE BY DATE: 2020-10-09; UPN # (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT SUFFERED FROM A STROKE AND IS NOW DECEASED. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184733 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VNMC4646C218TU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death