BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 24827066 · Received April 9, 2026

    Report

    Report Number
    2029214-2026-00636
    Event Type
    Death
    Date Received
    April 9, 2026
    Date of Event
    February 5, 2025
    Report Date
    April 9, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-SOLITAIRE (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A CITATION: GOYAL, M., OSPEL, J. M., GANESH, A., DOWLATSHAHI, D., VOLDERS, D., MÖHLENBRUCH, M. A., JUMAA, M. A., NIMJEE, S. M., BOOTH, T. C., BUCK, B. H., KENNEDY, J., SHANKAR, J. J., DORN, F., ZHANG, L., HAMETNE. ENDOVASCULAR TREATMENT OF STROKE DUE TO MEDIUM-VESSEL OCCLUSION. THE NEW ENGLAND JOURNAL OF MEDICINE 392(14):1385-1395 2025. DOI:10.1056/NEJMOA2411668 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    LITERATURE WAS REVIEWED REGARDING: ENDOVASCULAR TREATMENT OF STROKE DUE TO MEDIUM-VESSEL OCCLUSION (EVALUATION OF ENDOVASCULAR THROMBECTOMY PLUS USUAL CARE VERSUS USUAL CARE ALONE IN ACUTE ISCHEMIC STROKE CAUSED BY MEDIUM-VESSEL OCCLUSION). THE TIME FRAME OF THIS STUDY WAS: ENROLLMENT OCCURRED FROM APRIL 29, 2022 THROUGH JUNE 28, 2024, WITH PRIMARY FOLLOW-UP AT 90 DAYS AFTER RANDOMIZATION. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: SOLITAIRE X FAMILY STENT RETRIEVER WAS USED FOR THROMBUS-RETRIEVAL IN THE ENDOVASCULAR THROMBECTOMY (EVT) GROUP. THERE WERE 530 PATIENTS INCLUDED IN THE STUDY, 255 OF WHICH WERE ASSIGNED TO THE EVT GROUP. DEATHS OCCURRED IN THE STUDY POPULATION. THE CAUSES OF DEATH WERE: ¿ MORTALITY IN THE EVT GROUP 13.3%, OR 34 PATIENTS. SPECIFIC CAUSES OF DEATH WERE NOT FULLY DETAILED IN THE PUBLICATION, THOUGH IT WAS NOTED THAT SYMPTOMATIC HEMORRHAGE WAS ASSOCIATED WITH DEATH IN 7 PATIENTS IN THE EVT GROUP. AMONG PATIENT ADVERSE EVENTS IN THE EVT GROUP INCLUDED: ¿ THERE WERE 87 SERIOUS ADVERSE EVENTS OVERALL: ¿ PNEUMONIA (18 PATIENTS) ¿ RECURRENT STROKE (14 PATIENTS) ¿ STROKE PROGRESSION (14 PATIENTS) ¿ SYMPTOMATIC INTRACRANIAL HEMORRHAGE (14 PATIENTS) ¿ URINARY TRACT INFECTION (3 PATIENTS) ¿ COVID-19 (1 PATIENT) ¿ OTHER INFECTION (7 PATIENTS) ¿ NEW OR WORSENING CANCER (3 PATIENTS) ¿ SEIZURE (3 PATIENTS) ¿ CONGESTIVE HEART FAILURE (2 PATIENTS) ¿ ENDOCARDITIS (2 PATIENTS) ¿ PULMONARY EMBOLUS OR DEEP VENOUS THROMBOSIS (2 PATIENTS) ¿ ATRIAL FIBRILLATION (1 PATIENT) ¿ ARTERIAL-ACCESS COMPLICATION (2 PATIENTS) ¿ PROCEDURAL ARTERIAL INJURY (1 PATIENT) ¿ MAJOR PROCEDURAL COMPLICATIONS (E.G., VESSEL PERFORATION OR DISSECTION) OCCURRED IN 5 PATIENTS IN THE EVT GROUP. ¿ TECHNICAL EVT SUCCESS COULD NOT BE ACHIEVED IN ALL CASES, WITH APPROXIMATELY ONE QUARTER OF THE PATIENTS IN THE EVT GROUP HAVING AN INCOMPLETE REPERFUSION PATTERN (FINAL MEVO-ETICI SCORE OF 0 TO 2A) ON THE LAST INTRACRANIAL ANGIOGRAPHIC IMAGING. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887633 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death