BEUDAMED
    FDA Adverse Event Death Summary report: N

    REACT CATHETER

    MDR report key: 21781945 · Received April 5, 2025

    Report

    Report Number
    2029214-2025-00890
    Event Type
    Death
    Date Received
    April 5, 2025
    Date of Event
    October 1, 2023
    Report Date
    April 5, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K182097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    MATSUMOTO, S., SUZUKI, T., EMOTO, S., NAKASE, H., MATSUMURA, Y.; INTERNAL MEDICINE; 2024; 63: 3087-3091; A CEREBRAL EMBOLISM CAUSED BY A MALIGNANT PERIPHERAL NERVE SHEATH TUMOR IN A PATIENT WITH NEUROFIBROMATOSIS TYPE 1; DOI: 10.2169/INTERNALMEDICINE.2996-23 ARTICLE OBJECTIVE: THE DOCUMENT REPORTS A CASE OF A CEREBRAL EMBOLISM CAUSED BY A MALIGNANT PERIPHERAL NERVE SHEATH TUMOR (MPNST) IN A PATIENT WITH NEUROFIBROMATOSIS TYPE 1 (NF-1). THE PATIENT WAS A 31-YEAR-OLD MAN WHO UNDERWENT RESECTION OF THE MPNST ON THE BUTTOCK 3 MONTHS PRIOR TO PRESENTING WITH A HYPERACUTE LEFT MIDDLE CEREBRAL ARTERY EMBOLISM. THE CASE REPORT DETAILS EVENTS THAT OCCURRED OVER A HOSPITALIZATION PERIOD OF 15 DAYS. THE DOCUMENT DOES NOT EXPLICITLY STATE WHETHER MULTIPLE MANUFACTURERS' DEVICES WERE USED. IT PRIMARILY MENTIONS THE USE OF A SPECIFIC MEDTRONIC PRODUCT FOR MECHANICAL THROMBECTOMY. THE DOCUMENT MENTIONS THE USE OF THE ASPIRATION CATHETER REACT-71 FOR MECHANICAL THROMBECTOMY. THE PATIENT DIED ON THE 15TH DAY OF HOSPITALIZATION DUE TO RESPIRATORY FAILURE CAUSED BY LUNG METASTASIS OF THE MPNST. ADVERSE EVENTS/COMPLICATIONS: ON THE 14TH DAY OF ADMISSION, HIS CONSCIOUSNESS LEVEL DECREASED TO GCS E3V2M5, AND NEUROLOGICAL EXAMINATION DEMONSTRATED CONJUGATE DEVIATION OF THE LEFT EYE WITH RIGHT UPPER AND LOWER LIMB PARALYSIS. IN ADDITION, HIS RESPIRATORY CONDITION WORSENED TO SPO2 94% (O2 1 L/MIN). BRAIN COMPUTED TOMOGRAPHY (CT) REVEALED AN INTRATUMORAL HEMORRHAGE IN THE LEFT FRONTAL LOBE NEOPLASM. IN ADDITION, BODY CONTRAST CT REVEALED MULTIPLE TUMORAL LESIONS IN THE LEFT LUNG AND MASSIVE PLEURAL EFFUSION WITH ATELECTASIS IN THE RIGHT LUNG. CT DID NOT REVEAL ARTERIOSCLEROTIC LESIONS IN THE AORTA. ANOTHER TUMOR LESION WAS OBSERVED IN THE RIGHT KIDNEY. AS IT WAS CONSIDERED THAT THE PATIENT WOULD NOT BE ABLE TO TOLERATE SURGERY DUE TO SEVERE ATELECTASIS, CONSERVATIVE TREATMENT FOR THE INTRATUMORAL HEMORRHAGE AND DRAINAGE OF THE PLEURAL FLUID WAS CONDUCTED. ON THE 15TH DAY AFTER ADMISSION, HIS RESPIRATORY STATUS ABRUPTLY WORSENED AND HE DIED OF RESPIRATORY FAILURE. ON AUTOPSY, MULTIPLE NODULES OF THE MPNST OCCUPIED THE RIGHT LUNG. MOREOVER, A LUNG HISTOLOGICAL EXAMINATION OF THE AUTOPSY CONFIRMED TUMOR INVASION OF THE PULMONARY VEINS. THE RESULTS OF ELASTICA VAN GIESON STAINING CONFIRMED THAT THE LESION WAS VENOUS INVASION. MOST TUMOR CELLS HAD SPINDLE-SHAPED AND HYPERCHROMATIC NUCLEI THAT WERE IDENTIFIED AS MPNST. MULTIPLE VASCULAR INVASIONS OF THE MPNST, SUCH AS IN THE KIDNEYS AND RIGHT THYROID GLAND, WERE ALSO OBSERVED. VERRUCAE, CALCIFICATION OF THE VALVES, AND PATENT FORAMEN OVALE WERE NOT OBSERVED IN THE HEART. FURTHERMORE, THERE WAS NO EVIDENCE OF CEREBROVASCULAR ATHEROSCLEROSIS. IN ADDITION, THE HEMORRHAGE IN THE LEFT FRONTAL LOBE WAS HISTOPATHOLOGICALLY IDENTIFIED TO BE THE RESULT OF MPNST. THEREFORE, RESPIRATORY FAILURE DUE TO METASTATIC MPNST IN THE LUNGS AND CEREBRAL HEMORRHAGE CAUSED BY INTRACRANIAL MPNST WERE REGARDED AS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979789 REACT CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 REACT-71 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Death