BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MO.MA ULTRA

    MDR report key: 6329023 · Received February 14, 2017

    Report

    Report Number
    3004066202-2017-00022
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    September 10, 2016
    Report Date
    January 16, 2017
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF CONFERENCE P-288 CIRSE 2016 POSTERS COMPARISON OF EMBOLIZATION PROTECTION DEVICES WITH PROXIMAL BALLOON DEVICE AND -LTER DEVICE: PROCEDURAL COMPLICATIONS AND EMBOLIC INFARCTIONS ON DWI M.H.RHO, H.P.HONG RADIOLOGY, KANGBUK SAMSUNG HOSPITAL, SUNGKUNKWAN UNIVERSITY SCHOOL OF MEDICINE, SEOUL, KOREA. 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

    PURPOSE: PROXIMAL BALLOON-TYPE EMBOLIZATION PROTECTION DEVICE (EPD) AND DISTAL FILTER-TYPE EPD HAVE BEEN USED DURING CAS. THIS STUDY COMPARES THE RELATED COMPLICATIONS AND THROMBOEMBOLIC INFARCTIONS ON DIFFUSION WEIGHTED IMAGE (DWI) ENCOUNTERED USING THESE TWO TYPES OF EPDS. MATERIAL AND METHODS: A RETROSPECTIVE REVIEW OF 103 PATIENTS UNDERGOING CAS USING A BALLOON OCCLUSION EPD (MOMA) OR FILTER EPD (SPIDER FX, FILTERWIRE) WAS CONDUCTED. SYMPTOMATIC STENOSIS, DEGREE OF STENOSIS, SITE OF STENOSIS, ULCERATION, AND COLLATERAL STATUS WERE EVALUATED. COMPLICATIONS AND TECHNICAL, REVERSIBLE, AND NEUROLOGICAL COMPROMISES DURING EPD DEPLOYMENT WERE ASSESSED. PROCEDURE TIME, NEW INFARCTIONS ON DWI AFTER CAS (TINY: <(><<)>3 MM, SMALL: <(><<)>10 MM, MEDIUM: <(><<)> 20 MM, AND LARGE: >20 MM), AND 30-DAY CLINICAL RESULTS AFTER CAS ALSO WERE EVALUATED. RESULTS: SYMPTOMATIC AND ASYMPTOMATIC COMPLICATION RATE WAS SLIGHTLY HIGHER IN THE MOMA GROUP (20%) COMPARED WITH THE SPIDER GROUP (15%), AND IN-STENT THROMBOSIS WITH NEAR COMPLETE AND COMPLETE OCCLUSION WAS NOTED IN TWO PATIENTS IN THE MOMA GROUP DURING THE PROCEDURE. NEW TINY INFARCTIONS ON DWI WERE HIGHER IN THE SPIDER GROUP COMPARED WITH THE MOMA GROUP (P <(><<)> .05). THE 30-DAY STROKE RATE WAS 2.3% IN THE BALLOON GROUP (N_ =_ 43) AND 3.3% IN THE FILTER GROUP (N_=_ 60, P <(> <<)> .05). TECHNICAL DIFFICULTIES INCLUDED A 10% INCIDENCE OF INTOLERANCE DURING BALLOON DEPLOYMENT COMPARED WITH 0% IN THE FILTER GROUP (P = .043). CONCLUSION: BOTH BALLOON OCCLUSION AND FILTER DEVICES PROVIDE ACCEPTABLE RESULTS WITH SIMILAR COMPLICATION RATES AND CLINICAL RESULTS. ALTHOUGH FILTER SHOWED HIGHER NEW TINY INFARCTIONS THAN BALLOON OCCLUSION, THIS DEVICE CAN BE USED PREFERENTIALLY TO AVOID A 10% INCIDENCE OF INTOLERANCE ASSOCIATED WITH BALLOON OCCLUSION AND 4.7% INCIDENCE OF IN-STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113076 MO.MA ULTRA CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention