BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 6018968 · Received October 11, 2016

    Report

    Report Number
    2953200-2016-01786
    Event Type
    Death
    Date Received
    October 11, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 22, 2016
    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

    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

    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 A 40 CM TYPE B THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT SUBSEQUENTLY THE DISSECTION PROGRESSED DISTALLY BELOW THE RENAL ARTERIES RESULTING IN RETROGRADE FALSE LUMEN PERFUSION BEHIND THE STENT GRAFT. THE PATIENT RETURNED FOR REPAIR OF THE DISSECTION AND FALSE LUMEN PERFUSION. AT THE TIME OF THE SECONDARY PROCEDURE THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE AND THE PATIENT EXPIRED. THE PHYSICIAN STATED THAT THE DISSECTION PROGRESSION WAS DUE TO PREVIOUSLY UNDIAGNOSED MARFAN¿S SYNDROME, AND WAS NOT RELATED TO THE STENT GRAFT. THE PHYSICIAN FURTHER STATED THAT THE DEATH WAS DUE TO THE PATIENT¿S ¿STONE HEART¿ WHICH DID NOT ALLOW FOR RESUSCITATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668550 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF4646C150TU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| R