BEUDAMED
    FDA Adverse Event Death Summary report: N

    REACT CATHETER

    MDR report key: 19055336 · Received April 5, 2024

    Report

    Report Number
    2029214-2024-00586
    Event Type
    Death
    Date Received
    April 5, 2024
    Date of Event
    October 25, 2023
    Report Date
    April 5, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K180715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MASTHOFF, M., KRÄHLING, H., AKKURT, B. H., ELSHARKAWY, M., KÖHLER, M., ERGAWY, M., THOMAS, C., SCHWINDT, W., MINNERUP, J., STRACKE, P. (2023). EVALUATION OF EFFECTIVENESS AND SAFETY OF THE MULTIZONE NEVATM STENT RETRIEVER FOR MECHANICAL THROMBECTOMY IN ISCHEMIC STROKE. NEURORADIOLOGY: A JOURNAL DEDICATED TO NEUROIMAGING AND INTERVENTIONAL NEURORADIOLOGY, 65(12), 1777¿1785. HTTPS://DOI. ORG/10.1007/S00234-023-03236-4 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A STUDY OF 39 PATIENTS WHO UNDERWENT THROMBECTOMY PROCEDURES TO TREAT ISCHEMIC STROKE BETWEEN MARCH AND NOVEMBER 2022. THE STUDY WAS MAINLY EVALUATING THE SAFETY AND EFFICACY OF A NON-MEDTRONIC STENT RETRIEVER. HOWEVER, IT WAS NOTED THAT REACT-68 ASPIRATION CATHETERS AND REBAR-18 MICROCATHETER WERE USED IN THE PROCEDURES. NO DEVICE MALFUNCTIONS WERE REPORTED. TECHNICAL SUCCESS OF RECANALIZATION, DEFINED AS ACHIEVING A MTICI 2B OR HIGHER, WAS ACHIEVED IN 37/39 CASES. THE ARTICLE REPORTED THERE WERE NO MINOR OR MAJOR ADVERSE EVENTS WERE OBSERVED IN THE STUDY COHORT. HOWEVER, THE FOLLOWING POST-OPERATIVE ADVERSE EVENTS WERE NOTED: THERE WERE 4 PATIENT IN-HOSPITAL PATIENT MORTALITIES. IT WAS NOTED THAT NONE OF THE PATIENT DEATHS WERE DEVICE ASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546384 REACT CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 REACT-68 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death