BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 6172125 · Received December 13, 2016

    Report

    Report Number
    2953200-2016-02111
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    October 20, 2016
    Report Date
    December 8, 2016
    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

    CONCOMITANT MEDICAL PRODUCTS: VAMC4040C150TE, SN (B)(4). 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.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN PATIENT FOR ENDOVASCULAR TREATMENT OF A 67 MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AND ONE MONTH POST INDEX PROCEDURE THE PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE THAT LED TO PATIENT DEATH. THE DEVICE AND PROCEDURE RELATIONSHIP HAS NOT YET BEEN ASSESSED BY THE INVESTIGATOR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820795 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF4646C200TE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death