BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFLEX CATHETER

    MDR report key: 16404106 · Received February 20, 2023

    Report

    Report Number
    2029214-2023-00309
    Event Type
    Death
    Date Received
    February 20, 2023
    Date of Event
    September 1, 2019
    Report Date
    February 20, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CHENG Z, RAJAH G, GAO J, GENG X, DING Y. PASSING EXTRACRANIAL ARTERY OCCLUSION BY INTERMEDIATE CATHETER WITH EXPANDING MICROBALLOON (PEACE): A NOVEL ENDOVASCULAR THERAPY IN ACUTE TANDEM OCCLUSION STROKE. JOURNAL OF ENDOVASCULAR THERAPY. 2022; VOL. 29(5) 790¿797. DOI: 10.1177/15266028211064818. A2 67 YEARS IS THE AVERAGE AGE OF THE PATIENTS WHO PARTICIPATED IN THE STUDY. 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

    THE PURPOSE OF THE ARTICLE WAS TO REPORT A SINGLE-CENTER EXPERIENCE OF ENDOVASCULAR TREATMENT OF ATHEROSCLEROTIC TANDEM OCCLUSIONS IN ACUTE ISCHEMIC STROKE (AIS) USING AN INTERMEDIATE CATHETER WITH MICROBALLOON FOR TREATMENT OF TANDEM OCCLUSIONS.   A TOTAL OF 151 AIS PATIENTS WITH LARGE VESSEL OCCLUSION RECEIVED ENDOVASCULAR THERAPY AND A CONSECUTIVE SERIES OF PATIENTS (N = 26) (MEAN AGE 66.8 YEARS) WHO SUFFERED FROM TANDEM CERVICAL INTRACRANIAL OCCLUSIONS WERE TREATED USING THE PASSING EXTRACRANIAL ARTERY OCCLUSION BY INTERMEDIATE CATHETER WITH EXPANDING MICROBALLOON (PEACE) TECHNIQUE, WHICH INCLUDED THE USE OF NAVIEN SUPPORT CATHETER. INTRACRANIAL RECANALIZATION WAS ACHIEVED BY ASPIRATION OR STENT RETRIEVER AND THEN EMERGENCY STENTING WAS PERFORMED FOR EXTRACRANIAL INTERNAL CAROTID ARTERY (ICA) LESION. DEMOGRAPHIC, CLINICAL CHARACTERISTICS, PROCEDURAL DETAILS OF ENDOVASCULAR THERAPY, AND PROGNOSIS OUTCOME WERE ASSESSED. THE OUTCOMES OF TANDEM OCCLUSION GROUP WERE COMPARED WITH ISOLATED INTRACRANIAL OCCLUSION GROUP (N = 122) AND PREVIOUS STUDIES.   AT 90 DAYS AFTER STROKE ONSET, 69.2% OF PATIENTS HAD FAVORABLE FUNCTIONAL PROGNOSIS WITH A MRS OF 0 TO 2 IN THE TANDEM OCCLUSIONS GROUP, SLIGHTLY HIGHER THAN 66.4% IN THE ISOLATED INTRACRANIAL OCCLUSION GROUPS, ALTHOUGH NO SIGNIFICANT DIFFERENCE WAS FOUND. ONLY ONE PATIENT (3.8%) WAS FOUND TO HAVE SICH AFTER ENDOVASCULAR THERAPY IN THE TANDEM OCCLUSIONS GROUP, COMPARED TO 6.6% IN THE ISOLATED INTRACRANIAL OCCLUSION GROUPS WITH NO SIGNIFICANT DIFFERENCE. SIMILARLY, NO DIFFERENCE WAS OBSERVED IN THE RATES OF FATAL ICH (0% VS 1.6%), DEATH (11.5% VS 13.9%), PNEUMONIA (11.5% VS 15.6%), AND SEIZURE (0% VS 2.5%).   THERE WERE NO DEVICE ISSUES REPORTED RELATING TO THE USE OF THE NAVIEN CATHETER.   ADVERSE EVENTS INCLUDED: DEATH, SYMPTOMATIC INTRACRANIAL HEMORRHAGE, AND PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572176 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Death