BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3123085 · Received May 21, 2013

    Report

    Report Number
    2953200-2013-00939
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 23, 2012
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSIONS: (PARALYSIS). (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ACUTE DESCENDING THORACIC DISSECTION UNDER PHYSICIAN-SPONSORED IDE # (B)(4). THE ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. THE PATIENT INITIALLY PRESENTED WITH ACUTE CHEST, ABDOMEN AND BACK PAIN, AND A PULSE DIFFERENTIAL IN THE LOWER EXTREMITIES. A CT SCAN SHOWED AN ACUTE DESCENDING THORACIC DISSECTION WITH EVIDENCE OF MALPERFUSION OF THE LEFT KIDNEY. THE VALIANT STENT GRAFTS WERE IMPLANTED, INTENTIONALLY COVERING THE LEFT SUBCLAVIAN ARTERY. IVUS AND ECHOCARDIOGRAPHY AFTER THIS PROCEDURE DEMONSTRATED IMMEDIATE FLOW 22 STAGNATION IN THE FALSE LUMEN. EARLY THE NEXT MORNING AFTER THE PROCEDURE, THE PATIENT STARTED TO COMPLAIN OF NUMBNESS AND WEAKNESS IN BOTH LOWER EXTREMITIES. THE MEAN ARTERIAL PRESSURE WAS INCREASED AND A CEREBROSPINAL FLUID DRAIN WAS PLACED. IMPROVEMENT WAS SEEN BUT IN ORDER TO IMPROVE COLLATERAL BLOOD FLOW TO THE SPINAL CORD, A LEFT COMMON CAROTID TO AXILLARY ARTERY BYPASS WAS PERFORMED. A LUMBAR DRAIN WAS ALSO PLACED THE NEXT DAY TO HELP INCREASE SPINAL PERFUSION. MOTOR FUNCTION IMPROVED AFTER THESE INTERVENTIONS AND THE SUBJECT WAS ABLE TO BE DISCHARGED HOME WITH RESOLUTION OF THE PARAPARESIS ON POST-OP DAY 8. NO ADDITIONAL INFORMATION IS AVAILABLE, AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224839 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention