BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4251221 · Received November 14, 2014

    Report

    Report Number
    2953200-2014-02407
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED SUB-ACUTE AORTIC 280 MM DISSECTION OF THE THORACIC AORTA. THE SUB-ACUTE AORTIC DISSECTION RUPTURED THE FALSE LUMEN OF 10CM AND THEN SEALED ITSELF OFF BECOMING A CONTAINED RUPTURE OF THE FALSE LUMEN. THE PHYSICIAN PLANNED TO COVER THE LSA TO GET ENOUGH SEAL ZONE PROXIMALLY AND PLACE THE FABRIC OF THE VALIANT AT THE LCCA AND BUILD ALL THE WAY DOWN TO THE CELIAC ARTERY USING THREE VALIANT STENT GRAFT, 40/40/100 AND TWO DISTAL MAIN EXTENSION PIECES 40/36C/150 AND 36/32/150. ALL THREE STENT GRAFTS WERE PLACED AND THREE 22MM PLUGS FROM ANOTHER MANUFACTURER WERE PLACED IN THE FALSE LUMEN AT ITS NARROWEST POINT TO HELP SUPPORT THROMBOSIS. FINAL ANGIOGRAM WAS DONE AND IT WAS DETERMINED THAT THE PROXIMAL MAIN VALIANT STENT GRAFT WAS ENCROACHING UPON THE ORIFICE OF THE LCCA. THE PHYSICIAN DECIDED TO PLACE ANOTHER MANUFACTURER¿S STENT IN THE LCCA FROM THE LCCA CUT DOWN. AFTER PLACEMENT OF THIS STENT, ANOTHER ANGIOGRAM WAS DONE WHEN THE RETROGRADE AORTIC DISSECTION (RTAD) APPEARED. WHEN THE RTAD OCCURRED, THE PHYSICIAN REPAIRED IT WITH AN OPEN PROCEDURE AND CUT THE BARE METAL FREE FLOW OFF AND SEWED ANOTHER MANUFACTURER¿S STENT GRAFT TO THE REMAINDER OF THE VALIANT STENT GRAFT. IT WAS NOTED THAT THE RTAD HAD TO BE REPAIRED BY SURGICALLY REPLACING THE ANTERIOR AORTIC ARCH. THE PHYSICIAN STATED THE EVENT WAS RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE DISSECTION WAS SUCCESSFULLY RESOLVED. THE PHYSICIAN STATED THE PATIENT WAS EXTUBATED AND WAS DOING WELL NINE DAYS POST THE INITIAL PROCEDURE BUT HAS SOME LOWER LIMB WEAKNESS. REVIEW OF SEVERAL RETURNED ANGIO VIDEOS AT IMPLANT AND PRE-IMPLANT 3D RECON IMAGES CONFIRMED THAT THE PATIENT HAD A LARGE DIAMETER DISSECTING ANEURYSM THAT EXTENDED FROM JUST DISTAL OF THE LSA, DOWN INTO THE DESCENDING THORACIC. THE STENT GRAFTS WERE SEEN IMPLANTED ACROSS THE LCCA, EXTENDING INTO THE DESCENDING THORACIC AORTA. A STENT IS THEN SEEN PLACED INTO THE LCCA AND A POSSIBLE TYPE A DISSECTION IS ALSO OBSERVED. THE CAUSE OF THE EVENTS COULD NOT BE DETERMINED FROM THESE IMAGES. LIKELY PROCEDURE AND ANATOMY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736190 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04143169

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention