BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4131531 · Received October 1, 2014

    Report

    Report Number
    2953200-2014-01958
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 5, 2013
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE: OUTCOMES OF ENDOVASCULAR MANAGEMENT FOR COMPLICATED CHRONIC TYPE B AORTIC DISSECTION: EFFECT OF THE EXTENT OF STENT GRAFT COVERAGE AND ANATOMIC PROPERTIES OF AORTIC DISSECTION. MYUNGSU LEE, MD, DO YUN LEE, MD, MAN DEUK KIM, MD, MU SOOK LEE, MD, JONG YUN WON, MD, SUNG IL PARK, MD, YOUNG NAM YOON, MD, SAK LEE, MD, DONGHOON CHOI, MD, AND YOUNG-GUK KO, MD. J VASC INTERV RADIOL 2013; 24:1451¿1460. THE FOLLOWING REINTERVENTIONS INDICATIONS WERE REPORTED AS DISSECTION IN ASCENDING AORTA, TYPE I ENDOLEAK, DESCENDING DISSECTION, RUPTURE, OCCLUSION, STENT GRAFT KINKING, OPEN REPAIR, VESSEL BYPASS, AND DEATH. NO FURTHER INFORMATION IS AVAILABLE FOR THIS CASE. ABSTRACT PURPOSE: TO ASSESS THE EFFECT OF THE EXTENT OF STENT GRAFT COVERAGE AND ANATOMIC PROPERTIES OF AORTIC DISSECTION ON THE OUTCOMES OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR COMPLICATED CHRONIC TYPE B AORTIC DISSECTION (CCBAD) IN TERMS OF SURVIVAL, REINTERVENTION, AND FALSE LUMEN THROMBOSIS. MATERIALS AND METHODS: A RETROSPECTIVE ANALYSIS WAS PERFORMED OF 71 PATIENTS WHO UNDERWENT TEVAR FOR CCBAD. MEAN PATIENT AGE WAS 54.7 YEARS. DISTAL EXTENT OF STENT GRAFT COVERAGE WAS CATEGORIZED AS SHORT (= T7) OR LONG (= T8) COVERAGE. INDICATIONS OF REINTERVENTION WERE CATEGORIZED INTO THREE GROUPS: PROXIMAL, ALONGSIDE, AND DISTAL ACCORDING TO THE ANATOMIC RELATIONSHIP OF THE CULPRIT LESION AND THE STENT GRAFT. OVERALL SURVIVAL, REINTERVENTION-FREE SURVIVAL, AND EXTENT OF FALSE LUMEN THROMBOSIS WERE COMPARED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 97.2%. THE 1-YEAR, 3-YEAR, AND 5-YEAR OVERALL SURVIVAL RATES WERE 97.1%, 88.9%, AND 88.9%, AND 1-YEAR, 3-YEAR, AND 5-YEAR REINTERVENTION-FREE SURVIVAL RATES WERE 80.7%, 73.8%, AND 60.6%. THERE WERE NO DIFFERENCES IN OVERALL SURVIVAL, REINTERVENTION-FREE SURVIVAL RATES, AND EXTENT OF FALSE LUMEN THROMBOSIS BETWEEN THE GROUPS. IN THE SHORT COVERAGE GROUP, DISTAL REINTERVENTION WAS MORE FREQUENT IN PATIENTS WITH AN ABDOMINAL AORTIC DIAMETER = 37 MM COMPARED WITH PATIENTS WITH AN ABDOMINAL AORTIC DIAMETER O 37 MM (P ¼ .005). CONCLUSIONS: TEVAR WAS EFFECTIVE FOR CCBAD WITH A HIGH TECHNICAL SUCCESS RATE AND LOW MORTALITY. THE EXTENT OF STENT GRAFT COVERAGE DID NOT MAKE A DIFFERENCE IN TERMS OF SURVIVAL AND FALSE LUMEN THROMBOSIS. REINTERVENTIONS WERE MORE FREQUENTLY PERFORMED IN PATIENTS WITH A LARGE BASELINE ABDOMINAL AORTIC DIAMETER WHO WERE TREATED WITH SHORT STENT GRAFT COVERAGE, AND SO LONGER COVERAGE IS RECOMMENDED IN SUCH PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610243 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention