BEUDAMED
    FDA Adverse Event Death Summary report: N

    REACT CATHETER

    MDR report key: 19110572 · Received April 15, 2024

    Report

    Report Number
    2029214-2024-00665
    Event Type
    Death
    Date Received
    April 15, 2024
    Date of Event
    August 7, 2023
    Report Date
    January 10, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K182097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SPECIFIC DEVICE INFORMATION PROVIDED. SEE ATTACHED LITERATURE ARTICLE. THE DATE OF THE EVENT WAS NOT PROVIDED. THE DATE OF THE EVENT USED WAS THE DATE THAT THE ARTICLE WAS PUBLISHED. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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

    PALANISAMY, P., KRAMADHARI, H., BADACHI, S., KUMAR, S., AGGIPOTHU, B., MATHEW, T., RAGHUNANDAN, S., SUCHARITHA, M.V., DEEPALAM, D. S. ENDOVASCULAR MANAGEMENT OF CEREBRAL VENOUS THROMBOSIS: A TERTIARY-CENTRE EXPERIENCE. POL J RADIOL. 2023. 88: E349-E355. DOI: 10. 5114/PJR.2023.130768 SUMMARY: STROKE RELATED TO CEREBRAL VENOUS THROMBOSIS (CVT) IS UNCOMMON, WITH UNTOWARD LETHAL OUTCOMES. SYSTEMIC ANTICOAGULATION IS THE TREATMENT OF CHOICE. HOWEVER, SOME PATIENTS CAN BE RESISTANT TO THIS TREATMENT. ENDOVASCULAR MANAGEMENT WITH THROMBOLYSIS AND MECHANICAL THROMBECTOMY CAN BE A VIABLE OPTION IN SUCH CASES. WE RETROSPECTIVELY REVIEWED THE ENDOVASCULAR MANAGEMENT USED FOR CVT IN 8 PATIENTS WHO FAILED TO RESPOND TO STANDARD ANTICOAGULATION THERAPY BETWEEN DECEMBER 2017 AND DECEMBER 2022 IN OUR INSTITUTE. CLINICAL PROFILE, IMAGING PARAMETERS, ENDOVASCULAR PROCEDURE DETAILS, AND OUTCOMES IN TERMS OF ANGIOGRAPHIC FINDINGS AND CLINICAL FOLLOW-UP WERE ANALYSED. IN THIS PERIOD, A TOTAL OF 8 PATIENTS UNDERWENT MECHANICAL THROMBECTOMY. THE PROCEDURE WAS SUCCESSFUL IN ALL CASES (8/8 = 100%), AND 50% OF THEM SHOWED NEAR TOTAL/COMPLETE RECANALIZATION; PERFORATION OF THE CORTICAL VEINS WAS NOTED IN 2 CASES (~25%). AMONG THE 8 PATIENTS, ONE DIED (1/8 = 12.5%) DUE TO CARDIAC AETIOLOGY; THE REMAINING 7 PATIENTS (87.5%) SHOWED GOOD CLINICAL OUTCOME WITH A MODIFIED RANKIN SCALE SCORE 0 TO 2. CATHETER-DIRECTED THROMBOLYSIS WITH MECHANICAL THROMBOASPIRATION IS A SAFE AND EFFECTIVE TREATMENT FOR CEREBRAL VENOUS SINUS THROMBOSIS NOT RESPONDING TO ANTICOAGULATION. REPORTED EVENTS: ONE PATIENT (1/8 = 12.5%) WITH CONGENITAL HEART DISEASE AND CVT DIED ON THE SECOND DAY POST PROCEDURE DESPITE RECANALIZATION OF OCCLUDED DURAL VENOUS SINUSES AND SYSTEMIC ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024337 REACT CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 REACT-71 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death