BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3232437 · Received July 18, 2013

    Report

    Report Number
    2953200-2013-01377
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 22, 2013
    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). EVALUATION RESULTS AND CONCLUSIONS: (LEG WEAKNESS LIKELY RELATED TO LOW BLOOD PRESSURE). (MRI SHOWS NO STENT GRAFT RELATED ISSUES).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN INTRAMURAL HEMORRHAGE (IMH) WITH PENETRATING ULCERS. THE PROXIMAL AORTA WAS 28 MM IN DIAMETER. IT WAS REPORTED THAT ON THAT THE CASE WENT GREAT. HOWEVER, THREE DAYS POST INDEX PROCEDURE THE PHYSICIAN WANTED TO DO AN MRI DUE TO THE PATIENT DEVELOPING LEFT LEG WEAKNESS. THE PATIENT'S LEFT LEG IS WEAKER THAN THE RIGHT. THE MRI SHOWED NO DAMAGE, THE PATIENT IS GETTING STRONGER AND RECOVERING. THEY WERE HAVING PROBLEMS KEEPING THE PATIENT'S BLOOD PRESSURE UP AND THAT MAY HAVE BEEN THE CAUSE OF PROBLEM. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333081 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04030983

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR