BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFLEX CATHETER

    MDR report key: 17714375 · Received September 8, 2023

    Report

    Report Number
    2029214-2023-01628
    Event Type
    Death
    Date Received
    September 8, 2023
    Date of Event
    January 9, 2023
    Report Date
    September 8, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. REPORTED PATIENT AGE (65 YEARS) IS REPRESENTATIVE OF THE MEAN AGE OF PATIENTS INCLUDED IN THE STUDY "TOTAL OCCLUSION" SUBGROUP. A3. REPORTED PATIENT SEX (MALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENT IN THE STUDY "TOTAL OCCLUSION" SUBGROUP. B3. EARLIEST DATE OF PUBLICATION IS USED FOR REPORTED DATE OF EVENT. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER MEDTRONIC NEUROVASCULAR DEVICES (REACT ASPIRATION CATHETER, SOLITAIRE STENT RETRIEVER) AND SERIOUS ADVERSE EVENTS WITHOUT MORTALITY REPORTED IN THE 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

    NI, H., YANG, T., JIA, Z., SHI, H., LIU, S., & ZHAO, L. (2023). OUTCOMES IN ACUTE ISCHEMIC STROKE PATIENTS UNDERGOING ENDOVASCULAR THROMBECTOMY: CERVICAL INTERNAL CAROTID ARTERY PSEUDO-OCCLUSION VS. TRUE OCCLUSION. FRONTIERS IN NEUROLOGY, 13, 1106358. HTTPS: //DOI.ORG/10.3389/FNEUR.2022.1106358. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A RETROSPECTIVE ANALYSIS OF PATIENTS WITH APPARENT CERVICAL INTERNAL CAROTID ARTERY (CICA) WHO UNDERWENT THROMBECTOMY PROCEDURES BETWEEN JANUARY 2016 AND AUGUST 2021. 146 PATIENTS WERE ULTIMATELY INCLUDED IN THE STUDY GROUP. OF THE 146 PATIENTS, 79 HAD PSEUDO-OCCLUSION (PO) AND 67 HAD TOTAL OCCLUSION (TO). FOR ALL PATIENTS, AN INITIAL ANGIOGRAPHIC RUN WAS COMPLETED TO IDENTIFY WHETHER THE CICA WAS TRULY OCCLUDED AND TO ASCERTAIN THE ETIOLOGY OF THE OCCLUSION. FOR CASES OF CONFIRMED TRUE OCCLUSION, DIFFERENT THROMBECTOMY PROTOCOLS WERE ESTABLISHED FOR PATIENTS WITH ISOLATED OCCLUSION VS. TANDEM OCCLUSION. PATIENTS WITH ISOLATED OCCLUSION HAD A 6F NAVIEN INTERMEDIATE CATHETER NAVIGATED UNTIL DIRECT ASPIRATION RESISTANCE IN THE PROXIMAL ICA WAS ENCOUNTERED. IN CASES OF ATHEROSCLEROTIC DISEASE CONTRIBUTING EMBOLIC PROTECTION DEVICES AND BALLOON ANGIOPLASTY WERE USED. IN CASES OF OBSTRUCTION RELATED DISSECTION, STENTS WERE PLACED. SUCCESSFUL RECANALIZATION WAS ACHIEVED IN 57/67 CASES. NO DEVICE MALFUNCTIONS WAS REPORTED. THE SLIGHT MAJORITY OF PATIENTS IN THE TO GROUP WERE MALE AND THE MEAN AGE WAS 65. ADVERSE PATIENT EVENTS IN THE CICA TO GROUP INCLUDED: 10 PATIENTS DIED WITHIN 90 DAYS OF TREATMENT. CAUSE OF PATIENT DEATHS AND RELATIONSHIP TO THE PROCEDURE AND/OR DEVICE WAS NOT SPECIFIED IN THE ARTICLE. 31 PATIENTS HAD HEMORRHAGIC TRANSFORMATION, 6 OF WHICH HAD SYMPTOMATIC INTRACRANIAL HEMORRHAGE. 28 PATIENTS HAD POOR OUTCOME AS NOTED BY MODIFIED RANKIN SCALE (MRS) SCORE OF 3-6 AT THE 3 MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525344 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death