BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 24800911 · Received April 7, 2026

    Report

    Report Number
    2029214-2026-00615
    Event Type
    Death
    Date Received
    April 7, 2026
    Date of Event
    November 20, 2024
    Report Date
    April 7, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-RFX (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-SOLITAIRE (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-RFX (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A CITATION: SCOTT, C., ABDULRAHMAN, L., SNYDER, M., CASTILLO, L., LU, J., DUNLAP, E., <(>&<)> NAGARSHETH, K.. FUNCTIONAL OUTCOMES AND COMPLICATIONS OF CAROTID TANDEM LESIONS AFTER MECHANICAL THROMBECTOMY FOR TREATMENT OF LARGE-VESSEL OCCLUSION STROKE. VASCULAR AND ENDOVASCULAR SURGERY 59(4), 396¿400 2025. DOI:10.1177/15385744241301494 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

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF DEATH, HEMORRHAGIC CONVERSION, MIDLINE SHIFT >5 CM, MALIGNANT CEREBRAL EDEMA, RE-OCCLUSION, AND DISCHARGE TO HOSPICE IN ASSOCIATION WITH SOLITAIRE THROMBECTOMY UTILIZING THE NAVIEN CATHETER. THE TIME FRAME FOR THIS STUDY WAS FROM AUGUST 2012 TO AUGUST 2021. THE PURPOSE OF THIS ARTICLE WAS TO EXAMINE THE DIFFERENCE IN POST-OPERATIVE FUNCTIONAL STATUS AT DISCHARGE FOR PATIENTS TREATED WITH MECHANICAL THROMBECTOMY FOR AN ACUTE LARGE VESSEL OCCLUSION STROKE BASED ON THE PRESENCE OF A TANDEM CAROTID LESION. THE AUTHORS REVIEWED 589 CASES OF PATIENTS (114 PATIENTS WITH TANDEM OCCLUSIONS AND 475 PATIENTS WITH ISOLATED LESIONS) TREATED FOR LARGE VESSEL OCCLUSIONS USING A SOLITAIRE STENT IN A MECHANICAL THROMBECTOMY. OF THE 589 PATIENTS, THE AVERAGE AGE WAS 65 YEARS, 279 WERE FEMALE AND 310 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE OR NAVIEN CATHETER. IN ADDITION, THE AVERAGE MODIFIED RANKIN SCORE (MRS) AT DISCHARGE WAS 3.9 IN THE TANDEM OCCLUSION GROUP AND 3.5 IN THE ISOLATED INTRACRANIAL GROUP. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: IN HOSPITAL MORTALITY IN 56 PATIENTS HEMORRHAGIC CONVERSION IN 18 PATIENTS MIDLINE SHIFT >5 CM IN 61 PATIENTS MALIGNANT CEREBRAL EDEMA IN 39 PATIENTS RE-OCCLUSION IN 7 PATIENTS DISCHARGE TO HOSPICE IN 11 PATIENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860813 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| D SEE H11...