BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3123108 · Received May 21, 2013

    Report

    Report Number
    2953200-2013-00943
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    February 1, 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). RESULTS: INHERENT RISK OF PROCEDURE (STROKE); (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN). CONCLUSIONS: KNOWN INHERENT RISK OF A PROCEDURE (STROKE); (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 A CHRONIC DESCENDING THORACIC DISSECTION UNDER PHYSICIAN-SPONSORED (B)(4). THE ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. EXCLUSION OF THE THORACIC TEAR WAS CONFIRMED IN A COMPLETION ANGIOGRAM. POST-OPERATIVE CT SCANS HOWEVER DEMONSTRATED EVIDENCE OF RE-PERFUSION OF THE DISTAL FALSE LUMEN. AT AN UNSPECIFIED TIME POST IMPLANT, THE SUBJECT SUFFERED A STROKE. ON POST-OP DAY 6 THE SUBJECT WAS DISCHARGED TO A REHABILITATION FACILITY WITH DYSMETRIA IN THE LEFT ARM AND LEG. NO ADDITIONAL INFORMATION IS AVAILABLE AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224956 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention