BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3609413 · Received February 5, 2014

    Report

    Report Number
    2953200-2014-00172
    Event Type
    Death
    Date Received
    February 5, 2014
    Date of Event
    January 26, 2013
    Report Date
    January 6, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK, CEREBROVASCULAR ACCIDENT. PRE-OPERATIVELY DISSECTED THORACIC ANEURYSM. CAUSE IS UNKNOWN. CONCLUSION: PRE-OPERATIVELY DISSECTED THORACIC ANEURYSM. CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; SELECTIVE COVERAGE OF THE LEFT SUBCLAVIAN ARTERY WITHOUT REVASCULARIZATION IN PATIENTS WITH BILATERAL PATENT VERTEBROBASILAR JUNCTIONS DURING THORACIC ENDOVASCULAR AORTIC REPAIR. LEE M, LEE DO Y, KIM MD, WON JY, YUNE YN, LEE TY, CHOI D, KO YG. J VASC SURG. 2013 MAY;57(5):1311-6. DOI: 10.1016/J.JVS.2012.10.110. EPUB 2013 JAN 26. BETWEEN 2006 AND 2011 VALIANT STENT GRAFTS SYSTEM WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISEASE. OBJECTIVE: THE PRIMARY PURPOSE OF THE CURRENT STUDY WAS TO EVALUATE THE SAFETY AND EFFECTIVENESS OF SELECTIVE COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSCA) WITHOUT REVASCULARIZATION DURING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) IN PATIENTS WITH BILATERAL PATENT VERTEBROBASILAR JUNCTIONS. THE SECONDARY PURPOSE WAS TO ASSESS MORPHOLOGIC CHANGE OF THE VERTEBRAL ARTERY (VA) AFTER THE PROCEDURE. METHODS: AMONG 126 PATIENTS WHO UNDERWENT TEVAR BETWEEN 2006 AND 2011, 29 PATIENTS REQUIRING LSCA COVERAGE WITHOUT PREEMPTIVE REVASCULARIZATION WERE RETROSPECTIVELY ANALYZED IN THIS STUDY. THE PATIENTS WERE A MEAN AGE OF 63.1 YEARS (RANGE, 45-84 YEARS). THE MEAN FOLLOW-UP PERIOD WAS 19.9 MONTHS (RANGE, 1-63 MONTHS). BILATERAL PATENT VERTEBROBASILAR JUNCTIONS WERE EVALUATED BY CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT), TIME-OF FLIGHT MAGNETIC RESONANCE ANGIOGRAPHY, OR CONVENTIONAL ANGIOGRAPHY. NEUROLOGIC COMPLICATIONS, SUCH AS SPINAL CORD ISCHEMIA (SCI) OR CEREBROVASCULAR ACCIDENTS, WERE ANALYZED. PREPROCEDURAL AND POSTPROCEDURAL CHANGES IN VAS WERE EVALUATED ON FOLLOW-UP CONTRAST-ENHANCED CT. RESULTS: THE OVERALL 30-DAY MORTALITY WAS 6.9% (2 OF 29). NONE OF THE PATIENTS HAD SCI OR A STROKE OF POSTERIOR CIRCULATION ALONE. CEREBROVASCULAR ACCIDENTS FROM EMBOLIC INFARCTIONS OCCURRED IN TWO PATIENTS (7.4%). TRANSIENT LEFT ARM ISCHEMIC SYMPTOMS WERE PRESENT IN FIVE PATIENTS (18.5%), BUT NONE REQUIRED SECONDARY INTERVENTIONS. DELAYED DEVELOPMENT OF TYPE I ENDOLEAK OCCURRED DUE TO STENT DEFORMITY IN ONE PATIENT, WHO UNDERWENT SURGERY. ONE PATIENT REQUIRED REINTERVENTION AFTER THE 10-MONTH FOLLOW-UP CONTRAST-ENHANCED C T SHOWED A PSEUDOANEURYSM HAD DEVELOPED AT THE DISTAL MARGIN OF THE PREVIOUSLY PLACED STENT GRAFT. HYPERTROPHY OF THE RIGHT VA AFTER TEVAR WAS SEEN IN SEVEN OF 27 PATIENTS (25.9%); TWO PATIENTS SHOWED BILATERAL HYPERTROPHY OF VAS. CONCLUSIONS: LSCA COVERAGE WITHOUT REVASCULARIZATION CAN BE SAFELY PERFORMED DURING TEVAR IN PATIENTS WITH BILATERAL PATENT VERTEBROBASILAR JUNCTIONS. HYPERTROPHY OF THE RIGHT VA WAS NOTED IN 25.9% OF PATIENTS AFTER LSCA COVERAGE. SEAL THORACIC OR VALIANT DEVICES WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75169 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R