BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 4121775 · Received September 26, 2014

    Report

    Report Number
    2953200-2014-01937
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    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

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE TREATMENT OF A THORACIC DESCENDING AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY. THE PATIENT WAS STABILIZED AND PREPARED FOR AN ENDOGRAFT. THE POOR QUALITY CT SHOWED A THORACIC DISSECTION AND RUPTURE. FENESTRATION OR FENESTRATIONS OF THE INTIMA COULD NOT BE SEEN ON THE CT. INTRA-OPERATIVE IVUS DEMONSTRATED A PROXIMAL (AT OR SLIGHTLY DISTAL TO THE LSA) FENESTRATION AND ANGIOGRAM SHOWED RUPTURE / EXTRAVASATION IN ROUGHLY THE SAME AREA. THE IMPLANT HALTED THE BLOOD LOSS AND FALSE LUMEN FILLING OF CONTRAST. THE PATIENT WAS RECOVERING WELL. THE FOLLOWING DAY BLEEDING RESUMED IN LARGE QUANTITY AS EVIDENCED BY CHEST TUBE DRAINAGE. INTRA-OP ANGIOGRAM SHOWED A NEW FENESTRATION 3-4CM DISTAL TO THE GRAFT WITH FALSE LUMEN FLOW BACK TO THE RUPTURE SITE. THE PATIENT EXPIRED. A REVIEW OF RETURNED PRE-IMPLANT CTA'S CONFIRMED THAT THE PATIENT HAD AN AORTIC DISSECTION BEGINNING JUST BELOW THE ARCH NEAR THE LSA, EXTENDING DISTALLY INTO BOTH ILIAC ARTERIES. THERE WAS A 5CM TAA IN THE MID-DESCENDING THORACIC. THE THORACIC DIAMETER AT THE LEVEL OF THE LSA WAS APPROXIMATELY 30MM AND JUST PROXIMAL TO THE CELIAC WAS 32MM. IMAGES DURING AND POST-IMPLANT WERE NOT PROVIDED. THE CAUSE OF THE EVENTS COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601381 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04251765

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Death