BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT SYSTEM

    MDR report key: 2823095 · Received November 7, 2012

    Report

    Report Number
    2953200-2012-02143
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (PARALYSIS). (UNKNOWN CAUSE OF EVENT). CONCLUSIONS: (UNKNOWN CAUSE OF EVENT).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. THE PATIENT HAD A PREVIOUS AAA REPAIR WITH A TUBE GRAFT PLACED IN THE ABDOMINAL AORTA SO A SPINAL DRAIN WAS PLACED. IT WAS REPORTED THAT THE PATIENT'S LEFT LEG WENT FLACCID 8 HOURS POST OP. THE PATIENT REGAINED PROXIMAL FUNCTION BY MAXIMIZING THINGS WITH DRAIN BUT THE PATIENT WILL NEED INTENSIVE REHAB. IT WAS NOTED THAT THE PLACEMENT OF THE THORACIC GRAFT INCREASED THE CHANCES OF PARALYSIS. THE PHYSICIAN WILL MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01081156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention