BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4096563 · Received September 17, 2014

    Report

    Report Number
    2953200-2014-01851
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    June 3, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. EMERGENCY ENDOVASCULAR STENT GRAFTING IN ACUTE COMPLICATED TYPE B DISSECTION. (J VASC SURG 2014;-:1-5.) DOMINIK WIEDEMANN, MD, MAREK EHRLICH, MD, PHILIPPE AMABILE, MD, LUIGI LOVATO, MD, HERVÉ ROUSSEAU, MD, ARTURO EVANGELISTA-MASIP, MD, PATRICK MOELLER, MD, AND JOSEPH BAVARIA, MD. DX.DOI.ORG/10.1016/J.JVS.2014.06.001 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DISSECTION, RENAL FAILURE, NEUROLOGIC DEFICIT, MESENTERIC ISCHEMIA, GASTROINTESTINAL BLEEDING, HEMOTHORAX/SECONDARY RUPTURE, LIVER MALPERFUSION, LOWER LIMB ISCHEMIA, DEATH, SEPTICEMIA, ANEURYSM RUPTURE, ENDOLEAK NO FURTHER INFORMATION IS AVAILABLE. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO ASSESS MIDTERM RESULTS OF EMERGENCY ENDOVASCULAR STENT GRAFTING FOR PATIENTS WITH LIFE-THREATENING COMPLICATIONS OF ACUTE TYPE B AORTIC DISSECTION. METHODS: BETWEEN MARCH 1999 AND NOVEMBER 2011, 110 PATIENTS (86 MEN, 24 WOMEN) WITH COMPLICATIONS OF ACUTE TYPE B AORTIC DISSECTION (MEAN AGE, 61 YEARS; RANGE, 19-87 YEARS) WERE TREATED WITH THORACIC ENDOVASCULAR AORTIC REPAIR FOR MALPERFUSION (55.5%) OR AORTIC RUPTURE (53.6%) IN FIVE MAJOR EUROPEAN REFERRAL CENTERS AND ONE U.S. REFERRAL CENTER. ADDITIONAL COMORBIDITIES INCLUDED HYPERTENSION IN 90 PATIENTS (82%), DIABETES IN 14 PATIENTS (13%), AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE IN SIX PATIENTS (6%). ELEVEN PATIENTS (10%) HAD UNDERGONE PREVIOUS AORTIC SURGERY. RESULTS: OVERALL HOSPITAL MORTALITY WAS 12% (N [ 13), WITH 14 LATE DEATHS AFTER HOSPITAL DISCHARGE. IN-HOSPITAL COMPLICATIONS OCCURRED IN 32 PATIENTS (36%); 10 PATIENTS DEVELOPED POSTOPERATIVE RENAL FAILURE, FIVE PATIENTS EXPERIENCED NEW PERMANENT NEUROLOGIC SYMPTOMS, AND SIX PATIENTS (5.4%) EXPERIENCED RETROGRADE TYPE A AORTIC DISSECTION. FURTHERMORE, NINE PATIENTS (8%) DEVELOPED AN EARLY TYPE I ENDOLEAK. ACTUARIAL SURVIVAL AT 1 AND 5 YEARS WAS 85% AND 73%, RESPECTIVELY. POSTPROCEDURAL COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED COMPLETE OR PARTIAL THROMBOSIS OF THE FALSE LUMEN AT THE STENTGRAFT LEVEL IN 61% AND 23% OF ALL PATIENTS, RESPECTIVELY. FREEDOM FROM TREATMENT FAILURE ACCORDING TO THE STANFORD CLASSIFICATION WAS 82%, 75%, AND 59% AT 1, 3, AND 5 YEARS. CONCLUSIONS: ENDOVASCULAR REPAIR OF COMPLICATED ACUTE TYPE B AORTIC DISSECTION IS PROVEN TO BE A TECHNICALLY FEASIBLE AND EFFECTIVE TREATMENT MODALITY IN THIS RELATIVELY DIFFICULT PATIENT COHORT. SHORT-TERM AND MIDTERM RESULTS ARE PERSUASIVE; HOWEVER, THE LONG-TERM EFFICACY NEEDS TO BE FURTHER EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574412 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention