BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 4572448 · Received March 5, 2015

    Report

    Report Number
    2953200-2015-00432
    Event Type
    Death
    Date Received
    March 5, 2015
    Date of Event
    March 3, 2014
    Report Date
    March 5, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NONE OF THE ADVERSE EVENTS WERE DIRECTLY RELATED TO A MEDTRONIC PRODUCT. IT WAS NOTED THAT ALL THE ADVERSE EVENTS WERE RELATED WITH THE SURGICAL PROCEDURES, AND NOTHING SPECIFICALLY RELATED TO THE DEVICES.

    Description of Event or Problem · 1

    HYBRID TREATMENT OF AORTIC ARCH DISEASE. PATRICK BASTOS METZGER1, MD; FABIO HENRIQUE ROSSI2, MD, PHD; SAMUEL MARTINS MOREIRA3, MD; MARIO ISSA4, MD, PHD; NILO MITSURU IZUKAWA5, MD, PHD; JARBAS J. DINKHUYSEN6, MD, PHD; DOMINGOS SPINA NETO7, MD; ANTÔNIO MASSAMITSU KAMBARA8, MD, PHD. DOI: 10.5935/1678-9741.20140056 ON UNKNOWN DATES BETWEEN JANUARY 2010 AND DECEMBER 2012, UNKNOWN VALIANT STENT GRAFTS WERE IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: CARDIAC TAMPONADE, PARAPLEGIA , PULMONARY COMPLICATIONS , ISCHEMIC CEREBROVASCULAR ACCIDENT , ACUTE RENAL FAILURE , ACUTE MYOCARDIAL INFARCTION, RETROGRADE TYPE A DISSECTION, RUPTURE, AND DEATH. IT WAS ALSO REPORTED THAT THERE WERE TYPE IA, AND TYPE III ENDOLEAKS AND THREE RE-INTERVENTION WERE REQUIRED. INTRODUCTION: THE MANAGEMENT OF THORACIC AORTIC DISEASE INVOLVING THE ASCENDING AORTA, AORTIC ARCH AND DESCENDING THORACIC AORTA ARE TECHNICALLY CHALLENGING AND IS AN AREA IN CONSTANT DEVELOPMENT AND INNOVATION. OBJECTIVE: TO ANALYZE EARLY AND MIDTERM RESULTS OF HYBRID TREATMENT OF ARCH AORTIC DISEASE. METHODS: RETROSPECTIVE STUDY OF PROCEDURES PERFORMED FROM JANUARY 2010 TO DECEMBER 2012. THE END POINTS WERE THE TECHNICAL SUCCESS, THERAPEUTIC SUCCESS, MORBIDITY AND MORTALITY, NEUROLOGIC OUTCOMES, THE RATE OF ENDOLEAKS AND REINTERVENTIONS. RESULTS: A TOTAL OF 95 PATIENTS TREATED FOR THORACIC AORTIC DISEASES IN THIS PERIOD, 18 UNDERWENT HYBRID TREATMENT AND ENTERED IN THIS STUDY. THE AVERAGE AGES WERE 62.3 YEARS. THE MALE WAS PRESENT IN 66.7%. THE TECHNICAL AND THERAPEUTIC SUCCESS WAS 94.5% E 83.3%. THE PERIOPERATIVE MORTALITY RATE OF 11.1%. THERE IS ANY DEATH DURING ONE-YEAR FOLLOW- UP. THE REOPERATION RATES WERE 16.6% DUE 2 CASES OF ENDOLEAK IA AND ONE CASE OF ENDOLEAK II. THERE IS ANY OCCLUSION OF ANATOMIC OR EXTRA ANATOMIC BYPASS DURING FOLLOW UP. CONCLUSION: IN OUR STUDY, THE HYBRID TREATMENT OF AORTIC ARCH DISEASE PROVED TO BE A FEASIBLE ALTERNATIVE OF CONVENTIONAL SURGERY. THE THERAPEUTIC SUCCESS RATES AND RE- INTERVENTIONS OBTAINED DEMONSTRATE THE NECESSITY OF THOROUGH CLINICAL FOLLOW-UP OF THESE PATIENTS IN A LONG TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155330 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Death| R