BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 4922191 · Received July 17, 2015

    Report

    Report Number
    2953200-2015-01052
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    May 19, 2015
    Report Date
    June 25, 2015
    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

    (B)(4)

    Description of Event or Problem · 1

    EARLY RESULTS OF CHIMNEY TECHNIQUE FOR TYPE B AORTIC DISSECTIONS EXTENDING TO THE AORTIC ARCH CHEN HUAN, HANFEI TANG, TONG QUAO, CH ANGJIAN LIU, MIN ZHOU, CARDIOVASC INTERVENT RADIOL; 2015 1145-9 VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF TYPE B THORACIC AORTIC DISSECTIONS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE I ENDOLEAK. ABSTRACT OBJECTIVE: TO SUMMARIZE OUR EARLY EXPERIENCE GAINED FROM THE CHIMNEY TECHNIQUE FOR TYPE B AORTIC DISSECTION (TBAD) EXTENDING TO THE AORTIC ARCH AND TO EVALUATE THE AORTIC REMODELING IN THE FOLLOW-UP PERIOD. METHODS: FROM SEPTEMBER 2011 TO JULY 2014, 27 CONSECUTIVE TBAD PATIENTS WITHOUT ADEQUATE PROXIMAL LANDING ZONES WERE RETROGRADE ANALYZED. CHIMNEY STENT-GRAFTS WERE DEPLOYED PARALLEL TO THE MAIN ENDOGRAFTS TO RESERVE FLOW TO BRANCH VESSELS WHILE EXTENDING THE LANDING ZONES. IN THE FOLLOW-UP PERIOD, AORTIC REMODELING WAS OBSERVED WITH COMPUTED TOMOGRAPHY ANGIOGRAPHY. RESULTS: THE TECHNICAL SUCCESS RATE WAS 100 %, AND ENDOGRAFTS WERE DEPLOYED IN ZONE 0 (N = 3, 11.1 %), ZONE 1 (N = 18, 66.7 %), AND ZONE 2 (N = 6, 22.2 %). IMMEDIATELY, PROXIMAL ENDOLEAKS WERE DETECTED IN 5 PATIENTS (18.5 %). DURING A MEAN FOLLOW-UP PERIOD OF 17.6 MONTHS, COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED ALL THE AORTIC STENT-GRAFTS AND CHIMNEY GRAFTS TO BE PATENT. FAVORABLE REMODELING WAS OBSERVED AT THE LEVEL OF MAXIMUM DESCENDING AORTA AND LEFT SUBCLAVIAN ARTERY WITH EXPANSION OF TRUE LUMEN (FROM 18.4 ± 4.8 TO 25 ± 0.86 MM, P\0.001 AND 27.1 ± 0.62 TO 28.5 ± 0.37 MM, P\0.001) AND DEPRESSURIZATION OF FALSE LUMEN (FROM 23.7 ± 2.7 TO 8.7 ± 3.8 MM, P\0.001, FROM 5.3 ± 1.2 TO 2.1 ± 2.1 MM, P\0.001). WHILE AT THE LEVEL OF MAXIMUM ABDOMINAL AORTA, SUBOPTIMAL REMODELING OF THE TOTAL AORTA (FROM 24.1 ± 0.4 TO 23.6 ± 1.5 MM, P = 0.06) AND TRUE LUMEN (FROM 13.8 ± 0.6 TO 14.5 ± 0.4 MM, P = 0.08) WAS OBSERVED. CONCLUSION: BASED ON OUR LIMITED EXPERIENCE, THE CHIMNEY TECHNIQUE WITH THORACIC ENDOVASCULAR REPAIR IS DEMONSTRATED TO BE PROMISING FOR TBAD EXTENDING TO THE ARCH WITH FAVORABLE AORTIC REMODELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466617 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention