BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 6199463 · Received December 22, 2016

    Report

    Report Number
    2953200-2016-02154
    Event Type
    Death
    Date Received
    December 22, 2016
    Date of Event
    August 30, 2016
    Report Date
    February 14, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THAT THE CEC HAD ASSESSED THIS EVENT AS PROCEDURAL, DEVICE AND ANEURYSM RELATED. THE CAUSE OF DEATH WAS MULTIPLE ORGAN FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF THE PRE-OPERATIVE RUPTURE OF A THORACIC AORTIC DISSECTING FALSE ANEURYSM. IT WAS REPORTED THAT THE PATIENT DIED. THE INVESTIGATOR ASSESSED THE CAUSE TO BE DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851168 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF2626C100TE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death