BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4152777 · Received October 8, 2014

    Report

    Report Number
    2953200-2014-02013
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    March 20, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. ENDOVSILENT CEREBRAL ISCHEMIA AFTER THORACIC ENDOVASCULAR AORTIC REPAIR: A NEUROIMAGING STUDY PHILIPP KAHLERT, MD, FESC, HOLGER EGGEBRECHT, MD, FESC, ROLF A. J¿ANOSI, MD, HEIKE A. HILDEBRANDT, MD, BJ¿ORN PLICHT, MD, KONSTANTINOS TSAGAKIS, MD, CHRISTOPH MOENNINGHOFF, MD, FELIX NENSA, MD, PETRA MUMMEL, MD, GERD HEUSCH, MD, FRCP, HEINZ G. JAKOB, MD, MICHAEL FORSTING, MD, RAIMUND ERBEL, MD, FESC, AND MARC SCHLAMANN, MD HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ENDOLEAK, ISCHEMIA, MALPERFUSION OF THE LSA NO FURTHER INFORMATION IS AVAILABLE. BACKGROUND. THE RISK OF CLINICALLY APPARENT, PERIPROCEDURAL STROKE AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) DUE TO DISLODGEMENT AND EMBOLIZATION OF AORTIC DEBRIS FROM INTRAVASCULAR MANIPULATION OF GUIDEWIRES, CATHETERS, AND LARGE-BORE DELIVERY SYSTEMS RANGES BETWEEN 2% AND 6% AND HAS BEEN ASSOCIATED WITH INCREASED POSTOPERATIVE MORTALITY. THE RATE OF CLINICALLY SILENT CEREBRAL ISCHEMIA IS YET UNKNOWN, BUT MAY BE EVEN HIGHER. METHODS. NINETEEN PATIENTS (13 MALE, 6 FEMALE) WHO UNDERWENT TEVAR WERE INCLUDED INTO THIS DESCRIPTIVE STUDY. PERIPROCEDURAL APPARENT AND SILENT CEREBRAL ISCHEMIA WAS ASSESSED BY DAILY CLINICAL NEUROLOGIC ASSESSMENT AND SERIAL CEREBRAL DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING (DW-MRI) AT BASELINE AND 5 DAYS (MEDIAN, INTERQUARTILE RANGE: 3.5) AFTER THE PROCEDURE. RESULTS. THE TEVAR WAS SUCCESSFUL IN ALL PATIENTS WITHOUT IMMEDIATE CLINICALLY APPARENT NEUROLOGIC DEFICITS. POSTINTERVENTIONAL CEREBRAL DW-MRI DETECTED A TOTAL OF 29 NEW FOCI OF RESTRICTED DIFFUSION IN 12 OF 19 TEVAR PATIENTS (63%). LESIONS WERE USUALLY MULTIPLE (1 TO 6 LESIONS PER PATIENT) AND RANGED IN SIZE BETWEEN 15 MM3 AND 300 MM3; 16 LESIONS WERE FOUND IN THE LEFT HEMISPHERE, 13 LESIONS IN THE RIGHT HEMISPHERE. OVERSTENTING OF THE LEFT SUBCLAVIAN ARTERY WAS PERFORMED IN 8 CASES, BUT WAS NOT ASSOCIATED WITH LATERALIZATION OF LESIONS. THERE WERE NO ADDITIONAL APPARENT NEUROLOGIC EVENTS DURING THE IN-HOSPITAL PERIOD. CONCLUSIONS. THORACIC ENDOVASCULAR AORTIC REPAIR RESULTED IN A HIGH INCIDENCE OF NEW FOCI OF RESTRICTED DIFFUSION ON CEREBRAL DW-MRI IN A PATTERN SUGGESTIVE OF PERIPROCEDURAL EMBOLIZATION. ALTHOUGH MULTIPLE LESIONS PER PATIENTS WERE FOUND, THESE LESIONS WERE NOT ASSOCIATED WITH APPARENT NEUROLOGIC DEFICITS DURING THE IN-HOSPITAL PERIOD. FURTHER DEVELOPMENTS IN TEVAR SHOULD BE DIRECTED TOWARD REDUCING THE RISK OF PERIPROCEDURAL CEREBRAL EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630717 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention