BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA STENT GRAFT SYSTEM

    MDR report key: 2809798 · Received October 31, 2012

    Report

    Report Number
    2953200-2012-02076
    Event Type
    Death
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 4, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; DIC). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; DIC).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.3 CM IN DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT HAD AN ASCENDING AORTA REPLACEMENT TWO YEARS AGO FOR TREATMENT OF A DISSECTION. THE PHYSICIAN IMPLANTED THE TWO VALIANT STENT GRAFTS IN ZONE 2 INTENTIONALLY COVERING THE LSA. THE PROCEDURE WAS COMPLETE WITH NO PROBLEMS. IT WAS REPORTED THAT ELEVEN DAYS POST INDEX PROCEDURE THE PATIENT HAD A DECREASE IN PLATELET COUNT AND BRAIN BLEEDING. THE PATIENT REMAINED IN THE HOSPITAL AND EXPIRED 9 DAYS LATER. THE PHYSICIAN BELIEVES THAT THE CAUSE OF DEATH WAS RELATED TO THE PATIENT'S PRE-EXISTING CONDITION OF DIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT CAPTIVIA STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01108955

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death