BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 6760400 · Received August 2, 2017

    Report

    Report Number
    2953200-2017-01219
    Event Type
    Injury
    Date Received
    August 2, 2017
    Date of Event
    June 28, 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 TITLED: ¿OUTCOMES AND AORTIC REMODELING AFTER PROXIMAL THORACIC ENDOVASCULAR AORTIC REPAIR OF POST TYPE B AORTIC DISSECTION THORACIC ANEURYSM.¿ ZHENYU SHI, A, JUN YANG, A, WEIGUO FU, DAQIAO GUO1, XIN XU, BIN CHEN, JUNHAO JIANG, JUE YANG, TING ZHU, ZHIHUI DONG, LIXIN WANG, YUN SHI, XIAO TANG, AND JIANING YUE (VASA (2016), 45 (4), 331 ¿ 336). 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

    THE FOLLOWING ADVERSE EVENTS AND PRODUCT PROBLEMS WERE REPORTED: DEATH, PARAPLEGIA, TYPE A RETROGRADE DISSECTION, TYPE B DISSECTION, INTRACRANIAL HEMORRHAGE, DISSECTION ANEURYSM EXPANSION, MULTIPLE ORGAN FAILURE, TYPE IA ENDOLEAK, TYPE IB ENDOLEAK. SUMMARY: BACKGROUND: THE OBJECTIVE WAS TO EXPLORE THE OUTCOMES AND AORTIC REMODELLING AFTER PROXIMAL THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) IN POST TYPE B AORTIC DISSECTION THORACIC ANEURYSM WITH A MAXIMAL DIAMETER = 5.5 CM. PATIENTS AND METHODS: 34 CASES OF TYPE B AORTIC DISSECTION THORACIC ANEURYSM UNDERGOING PROXIMAL TEVAR (COVERAGE OF THE PRIMARY ENTRY AND THE ANEURYSM EXTENT) FROM 2008 TO 2013 WERE RETROSPECTIVELY REVIEWED WITH FOLLOW-UP FOR AT LEAST 2 YEARS. THE PRIMARY ENDPOINTS WERE 30-DAY MORTALITY AND SURVIVAL AT 2 YEARS. THE SECONDARY ENDPOINTS WERE MAJOR COMPLICATION AND RE-INTERVENTION. THE AORTIC REMODELLING WAS INVESTIGATED BY COMPARISON OF THE MAXIMUM DIAMETER OF THE ANEURYSM AND THE DIAMETER OF TRUE AND FALSE LUMEN AT THE SAME LEVEL BETWEEN BASELINE AND 2 YEARS AFTER TEVAR. BESIDES, WE ALSO ANALYSED THE POSSIBLE RELEVANT FACTORS OF AORTIC REMODELLING INCLUDING THE COURSE OF DISSECTION, THE INVOLVEMENT OF DISSECTION, AND THE LENGTH AND SHAPE OF THE STENT GRAFT. RESULTS: THE 30 DAY MORTALITY WAS 2.9 % (1/34). THE PARAPLEGIA RATE POST-TEVAR WAS 2.9 % (1/34). OVERALL, 32 OUT OF THE 34 CASES WERE FOLLOWED-UP FOR 24 ¿ 79 MONTHS. AT 2 YEARS, THE OVERALL AND AORTIC SPECIFIC SURVIVAL WERE 87.5 % AND 90.3 % RESPECTIVELY. THE TWO YEAR FREEDOM FROM RE-INTERVENTION RATE WAS 87.5 %. COMPARED TO THE PREOPERATIVE DATA, MAXIMUM DIAMETER OF DESCENDING AORTA AT 2 YEARS DEMONSTRATED A SLIGHT INCREASE (65.4±14.1 MM VS 63.9±9.1 MM), BUT WITHOUT SIGNIFICANCE (P>0.05). MEANWHILE, WE NOTICED A SIGNIFICANT INCREASE OF TRUE LUMEN (P <(><<)> 0.01) AND DECREASE OF FALSE LUMEN (P <(><<)> 0.01) AT THE SAME LEVEL. RELEVANT ANALYSIS SHOWED THAT POSITIVE AORTIC REMODELLING OF THE MAXIMUM DIAMETER WAS ASSOCIATED WITH CHRONIC PHASE (= 90 DAYS OF DISSECTION ONSET) (P <(><<)> 0.05) AND THE APPLICATION OF 150 ¿ 170 MM STENT GRAFTS (P <(><<)> 0.05). CONCLUSIONS: PROXIMAL TEVAR OF POST TYPE B DISSECTION THORACIC ANEURYSM HAD GENERALLY FAVOURABLE SHORT- AND MID-TERM OUTCOMES WITH LOW PARAPLEGIA RATE. BESIDES, IT CAN ACHIEVE A CERTAIN EXTENT OF AORTIC REMODELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541063 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention| S