BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFLEX CATHETER

    MDR report key: 16415016 · Received February 21, 2023

    Report

    Report Number
    2029214-2023-00337
    Event Type
    Death
    Date Received
    February 21, 2023
    Date of Event
    April 17, 2018
    Report Date
    February 21, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT RELATED TO REGULATORY REPORT: 2029214-2023-00336. SEE FOR LITERATURE ARTICLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    ON (B)(6) 2023 LIT (HCP, FOR, LIT): DONG-HUN KANG, BYUNG MOON KIM, JI HOE HEO, HYO SUK NAM, YOUNG DAE KIM, YANG-HA HWANG, YONG-WON KIM, YONG-SUN KIM, DONG JOON KIM, HYO SUNG KWAK, HONG GEE ROH, YOUNG-JUN LEE, AND SANG HEUM KIM; JOURNAL OF NEUROSURGY; 2019; 131:1494-1500; EFFECT OF BALLOON GUIDE CATHETER UTILIZATION ON CONTACT ASPIRATION THROMBECTOMY; DOI: 10.3171/2018.6.JNS181045. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENT'S POTENTIALLY TREATED WITH CELLO BALLOON GUIDE CATHETERS (BGC) AND NAVIEN DISTAL ACCESS CATHETERS HAD COMPLICATIONS. THE AUTHORS AIMED TO TEST WHETHER THE BGC WAS ASSOCIATED WITH RECANALIZATION SUCCESS AND GOOD FUNCTIONAL OUTCOME IN CONTACT ASPIRATION THROMBECTOMY (CAT).  ALL PATIENTS WHO HAD UNDERGONE CAT AS THE FIRST-LINE TREATMENT FOR ANTERIOR CIRCULATION INTRACRANIAL LARGE VESSEL OCCLUSION WERE RETROSPECTIVELY IDENTIFIED FROM PROSPECTIVELY MAINTAINED REGISTRIES FOR SIX STROKE CENTERS. THE PATIENTS WERE DICHOTOMIZED INTO BGC UTILIZATION AND NON UTILIZATION GROUPS. A TOTAL OF 429 PATIENTS (MEAN AGE 68.4 YEARS; M/F RATIO 215:214) FULFILLED THE INCLUSION CRITERIA. A BGC WAS USED IN 45.2% OF PATIENTS. METHOD: FOR THOSE PATIENTS ELIGIBLE FOR INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) TREATMENT, TPA WAS ADMINISTERED. THE CAT PROCEDURES WERE PERFORMED WITH THE PATIENT UNDER LOCAL ANESTHESIA WITH OR WITHOUT CONSCIOUS SEDATION. BRIEFLY, A 6-FR GUIDE SHEATH OR 8-FR FROM OTHER MANUFACTURERS OR 9-FR BGC CELLO WAS USED AS A GUIDE CATHETER. ONCE THE GUIDE CATHETER WAS OPTIMALLY POSITIONED IN THE DISTAL CERVICAL VASCULATURE, A LARGE-BORE ASPIRATION CATHETER (EITHER NAVIEN DISTAL ACCESS CATHETER OR ONE FROM ANOTHER MANUFACTURER) WAS ADVANCED AS CLOSE AS POSSIBLE TO THE PROXIMAL END OF THE THROMBUS USING A COAXIAL TECHNIQUE WITH A 0.021- TO 0.027-INCH INNER LUMEN MICROCATHETER OVER A MICROWIRE. CAT WAS THEN PERFORMED WITH MANUAL ASPIRATION USING A 20- OR 50-ML SYRINGE. MORE SPECIFICALLY, A 50-ML SYRINGE WAS USED IN THE INTERNAL CAROTID ARTERY (ICA) OR M1 OCCLUSION, AND A 20-ML SYRINGE WAS SELECTIVELY USED IN THE M1 OCCLUSIONS. A PENUMBRA REPERFUSION CATHETER WAS PREDOMINANTLY USED FOR CAT IN ALL CENTERS DURING THE STUDY PERIOD. THE USE OF A BGC DEPENDED ON THE PROTOCOL AT EACH PARTICIPATING SITE, NOT EACH OPERATOR¿S PREFERENCE. SPECIFICALLY, TWO CENTERS HAD USED THE BGC IN ALMOST ALL CASES SINCE ITS INTRODUCTION EARLY IN 2012, WHEREAS THE OTHER FOUR CENTERS HAD NOT USED THE BGC AT ALL DURING THE STUDY PERIOD. THE TORTUOSITY OF THE RELEVANT CAROTID ARTERY LITTLE AFFECTED WHETHER A BGC WAS USED OR NOT. EXCEPT FOR BGC USE, THE CAT TOOLS AND TECHNIQUES WERE SIMILAR ACROSS ALL PARTICIPATING CENTERS. IN CASES IN WHICH A BGC WAS USED, THE BALLOON OF THE BGC WAS INFLATED AND THEN A PENUMBRA REPERFUSION CATHETER WAS CAUTIOUSLY RETRIEVED UNDER CONSTANT ASPIRATION WITH A 50-ML SYRINGE. THIS PROCESS WAS REPEATED UNTIL AN MTICI GRADE OF 2B OR 3 WAS ACHIEVED. OUTCOME: A GOOD OUTCOME WAS DEFINED AS MRS SCORE 0-2 AT 3 MONTHS. PATIENTS WERE DICHOTOMIZED INTO TWO GROUPS ACCORDING TO PROCEDURE: CAT WITH BGC (BGC GROUP) AND WITHOUT BGC (NON-BGC GROUP). A BGC WAS USED IN 45.2% OF PATIENTS. THE OVERALL RECANALIZATION AND GOOD OUTCOME RATES WERE 80.2% AND 52.0%, RESPECTIVELY. RECANALIZATION WAS ACHIEVED WITH CAT ALONE IN 67.1% OF PATIENTS AND AFTER A SWITCH TO OR THE SIMULTANEOUS USE OF A STENT RETRIEVER IN 13.0% OF PATIENTS. IN THE BGC GROUP THERE WERE 7 DEATHS AND 1 EMBOLISM TO A DISTAL OR DIFFERENT SITE, 38 HAD A HEMORRHAGIC INFARCT AND 15 HAD A PARENCHYMAL HEMATOMA. IN THE NON-BGC GROUP THERE WERE 17 DEATHS AND 8 EMBOLIZATIONS TO DISTAL OR DIFFERENT SITE. 45 HEMORRHAGIC INFARCTS AND 31 PARENCHYMAL HEMATOMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644106 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death