BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 4233292 · Received November 6, 2014

    Report

    Report Number
    2953200-2014-02340
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 ENDOVASCULAR TREATMENT OF A TRANSVERSE ARCH ANEURYSM IN ZONE ZERO AS WELL AS A DESCENDING ANEURYSM REPAIR. PRIOR TO IMPLANTING THE STENT GRAFTS, THE PATIENT WAS SCHEDULED FOR AN ARCH DE-BRANCH WITH A SIDE PORT ON THE SURGICAL GRAFT. THE ASCENDING ARCH MEASURED 38-40MM IT WAS REPORTED THAT THE PHYSICIAN PLACED A BENTSON WIRE DOWN THE DESCENDING AORTA TO USE IVUS TO DETERMINE THE PROXIMAL AND DISTAL LANDING ZONE SIZES AND LOCATION AND IT WAS DISCOVERED THERE WAS A TYPE A DISSECTION.. THE PHYSICIAN DID AN ASCENDING ARCH REPLACEMENT WITH A 34MM SURGICAL GRAFT TO FIX THE TYPE A DISSECTION. AFTER, THE THREE VALIANT STENT GRAFTS WERE IMPLANTED FROM THE CELIAC TO THE SURGICAL ASCENDING REPAIR. THE FINAL ANGIOGRAM WAS PERFORMED AND THE GRAFTS LOOKED GREAT WITH NO ENDOLEAKS OR MALFUNCTIONS. WHEN TAKING THE PATIENT OFF BYPASS, THE BLOOD PRESSURE STARTED TO BOTTOM OUT. THE PATIENT WAS PLACED BACK ON BYPASS AND A BALLOON PUMP WAS PLACED IN FROM THE LEFT GROIN. THE PATIENT EXPIRED SAME DAY. THE PHYSICIAN STATED THAT THE PATIENT DID NOT MAKE IT DUE TO COMPLICATIONS FROM THE TYPE A DISSECTION. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713817 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V05879890

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death| R