BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 6756270 · Received August 1, 2017

    Report

    Report Number
    2953200-2017-01201
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    February 10, 2016
    Report Date
    July 12, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE - INFLUENCE OF DISTAL EXTENSION OF FALSE LUMEN ON ADVERSE AORTIC EVENTS AFTER TEVAR IN PATIENTS WITH ACUTE TYPE B AORTIC DISSECTION. DU ZHAN-KUI, MBBS, WANG YA,MBBS, WANG XIAO-ZENG, MD, JING QUAN-MIN, MD, AND HAN YA-LING,MD. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 87:599¿607 (2016) DOI: 10.1002/CCD.26427. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TALENT AND VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF TYPE B THORACIC AORTIC DISSECTION. THE FOLLOWING INFORMATION IS IN THIS JOURNAL ARTICLE: STROKE, LIMB ISCHEMIA, PARAPLEGIA, ORGAN FAILURE, ENDOLEAKS, DEATH, PARAPLEGIA, RE-DISSECTION, RUPTURE. OBJECTIVE: TO INVESTIGATE THE CLINICAL OUTCOMES INFLUENCED BY DISTAL EXTENSION OF FALSE LUMEN IN ACUTE TYPE B AORTIC DISSECTION (TBAD) PATIENTS FOLLOWING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). METHODS: FROM APRIL 2002 TO JANUARY 2013, 264 TBAD PATIENTS TREATED WITH TEVAR WERE RETROSPECTIVELY ENROLLED. THE IIIA GROUP EXHIBITED A DISTAL FALSE LUMEN ABOVE THE DIAPHRAGM (N570), AND THE IIIB GROUP EXHIBITED A DISTAL FALSE LUMEN UNDER THE DIAPHRAGM (N5194). THE MORPHOLOGICAL CHARACTERISTICS AND ADVERSE EVENTS (30-DAY AND >30 DAYS) WERE RECORDED AND EVALUATED. RESULTS: THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS REGARDING THE DEMOGRAPHICS, COMORBIDITY PROFILES, OR INITIAL FEATURE OF COMPUTED TOMOGRAPHY ANGIOGRAPHY. THE INCIDENCE OF TRUE LUMEN COMPRESSION AND BRANCH INVOLVEMENT WERE SIGNIFICANTLY INCREASED IN THE IIIB GROUP COMPARED WITH THE IIIA GROUP (8.6% VS. 25.3%, RESPECTIVELY; 15.7% VS. 36.1%, RESPECTIVELY, BOTH P<(><<)> 0.05). THE 30-DAY MORTALITY RATE WAS 1.0% (2/194) IN THE IIIB GROUP, WHEREAS THE IIIA GROUP WAS ZERO. THE INCIDENCE OF EARLY ADVERSE EVENTS, THE 5-YEAR CUMULATIVE FREEDOM FROM ADVERSE EVENTS, AND THE 5-YEAR CUMULATIVE FREEDOM FROM ALL CAUSE MORTALITY RATE WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE IIIA AND IIIB GROUPS (2.9% VS. 6.7%, 81.4%, AND 80.4%, AND 95.7% VS. 93.8%, RESPECTIVELY, ALL P> 0.05). LOG-RANK TESTS ALSO INDICATED THERE WAS NO SIGNIFICANT DIFFERENCE. CONCLUSIONS: THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE IIIA AND IIIB GROUPS IN THE 5-YEAR MORALITY AND ADVERSE AORTIC EVENTS FOLLOWING TEVAR. THE DISTAL EXTENSION OF FALSE LUMEN PRIOR TO TEVAR DOES NOT INFLUENCE THE LONG-TERM MORALITY AND ADVERSE AORTIC EVENTS IN ACUTE TBAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537458 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention