BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 5068840 · Received September 10, 2015

    Report

    Report Number
    2953200-2015-01532
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    April 27, 2015
    Report Date
    August 19, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 ENTITLED; VOLUMETRIC ANALYSIS OF THE INITIAL INDEX COMPUTED TOMOGRAPHY SCAN CAN PREDICT THE NATURAL HISTORY OF ACUTE UNCOMPLICATED TYPE B DISSECTIONS. KEDAR S. LAVINGIA, MD, SEBASTION LARION, MS, SADAF S. AHANCHI, MD, CHAD P. AMMAR, MD, MOHIT BHASIN, MD, ALEEM K. MIRZA, BS, DAVID J. DEXTER, MD, AND JEAN M. PANNETON, MD HTTP://DX.DOI.ORG/10.1016/J.JVS.2015.04.449 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: SURGICAL CONVERSION, ANEURYSM ENLARGEMENT, RUPTURE, VASCULAR BYPASS CONVERSION OBJECTIVE: OUR OBJECTIVE WAS TO CHARACTERIZE THE PREDICTIVE IMPACT OF COMPUTED TOMOGRAPHY (CT) SCAN VOLUMETRIC ANALYSIS ON THE NATURAL HISTORY OF ACUTE UNCOMPLICATED TYPE B AORTIC DISSECTIONS (ADS). METHODS: WE CONDUCTED A RETROSPECTIVE REVIEW OF PATIENTS WITH ACUTE TYPE B ADS FROM 2009 TO 2014. ON AN INTUITION WORKSTATION ((B)(6)), VOLUME MEASUREMENTS WERE OBTAINED USING THE TRUE LUMEN VOLUME (TLV), FALSE LUMEN VOLUME (FLV), AND TOTAL AORTIC VOLUME FROM THE LEFT SUBCLAVIAN ARTERY TO THE CELIAC ARTERY. GROWTH RATE WAS CALCULATED AS THE CHANGE IN MAXIMAL DIAMETER BETWEEN FIRST AND LAST AVAILABLE CT SCANS DURING THE TIME INTERVAL. THE PRIMARY OUTCOME OF THE STUDY WAS DELAYED AORTIC INTERVENTION. P <(><<)> .05 WAS CONSIDERED STATISTICALLY SIGNIFICANT. RESULTS: DURING A 5-YEAR PERIOD, 164 PATIENTS HAD CTSCAN EVIDENCE OF ACUTE TYPEB ADS; 11 PATIENTS WERE EXCLUDED FOR LACK OF SUBSEQUENT FOLLOW-UP IMAGING; 36 PATIENTS WHO UNDERWENT URGENT REPAIR (<(><<)>14 DAYS FROM PRESENTATION) WERE ALSO EXCLUDED. WE EVALUATED A TOTAL OF 117 PATIENTS: 85 PATIENTS WHO DID NOT REQUIRE INTERVENTION AND 32 WHO UNDERWENT DELAYED (>14 DAYS) THORACIC ENDOVASCULAR ANEURYSM REPAIR (29) OR OPEN REPAIR (3). MEAN AGE WAS 66 6 12 YEARS. MEAN TLV/FLV RATIO ON INITIAL CT SCAN WAS SIGNIFICANTLY HIGHER IN PATIENTS WHO DID NOT EVENTUALLY REQUIRE AN OPERATION (1.55 VS 0.82; P[ .02). THE MEAN GROWTH RATE WAS HIGHER IN THOSE EVENTUALLY REQUIRING OPERATION (2.47 VS 0.42 MM/MO; P [ .003). PATIENTS WERE DIVIDED INTO THREE SUBGROUPS ON THE BASIS OF THEIR INITIAL IMAGING TLV/FLV RATIOS (<(><<)>0.8, 0.8-1.6, AND >1.6). THERE WAS A SIGNIFICANT DIFFERENCE IN THE GROWTH RATES BETWEEN THESE THREE GROUPS (4.6 VS 2.4 VS 0.8 MM/MO; P <(><<)> .025). AREA UNDER THE RECEIVER OPERATING CHARACTERISTIC CURVE ANALYSIS REVEALED THAT A TLV/FLV RATIO <(><<)>0.8 WAS HIGHLY PREDICTIVE FOR REQUIRING AN INTERVENTION (AREA [ 0.8; SENSITIVITY, 69%; SPECIFICITY, 84%: POSITIVE PREDICTIVE VALUE, 71%; NEGATIVE PREDICTIVE VALUE, 81%), WITH AN ODDS RATIO OF 12.2 (CONFIDENCE INTERVAL, 5-26; P <(><<)> .001). CONVERSELY, A TLV/FLV RATIO OF >1.6 WAS HIGHLY PREDICTIVE FOR FREEDOM FROM DELAYED OPERATION (SENSITIVITY, 91%; SPECIFICITY, 42%; POSITIVE PREDICTIVE VALUE, 61%; NEGATIVE PREDICTIVE VALUE, 86%). AFTER KAPLAN-MEIER ANALYSIS, 1-YEAR AND 2-YEAR SURVIVAL FREE OF AORTIC INTERVENTIONS WAS 60% AND 42% WITH A TLV/FLV RATIO <(><<)>0.8 AND 92% AND 82% WITH A RATIO >1.6 (P [ .001). CONCLUSIONS: INITIAL CT SCAN VOLUMETRIC ANALYSIS IN PATIENTS PRESENTING WITH UNCOMPLICATED ACUTE TYPE B ADS IS A USEFUL TOOL TO PREDICT GROWTH AND NEED FOR FUTURE INTERVENTION. (J VASC SURG 2015;-:1-7.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598753 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention