BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 21106652 · Received January 8, 2025

    Report

    Report Number
    2029214-2025-00086
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    January 2, 2024
    Report Date
    January 8, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 G2: CITATION: AUTHORS: NOGUEIRA RG, LOBSIEN D, KLISCH J, PIELENZ D, LOBSIEN E, SAUVAGEAU E, AGHAEBRAHIM N, MÖHLENBRUCH M, VOLLHERBST D, ULFERT C, BOZORGCHAMI H, CLARK W, PRIEST R, SAMANIEGO EA, ORTEGA-GUTIERREZ S, GHANNAM M. THROMBECTOMY WITH THE PRESET VS SOLITAIRE STENT RETRIEVERS AS FIRST-LINE LARGE VESSEL OCCLUSION STROKE TREATMENT A RANDOMIZED CLINICAL TRIAL. JAMA NEUROLOGY 81(2):170-178 2024. DOI:10.1001/JAMANEUROL.2023.5010 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: THROMBECTOMY WITH THE PRESET VS SOLITAIRE STENT RETRIEVERS AS FIRST-LINE LARGE VESSEL OCCLUSION STROKE TREATMENT. THE TIME FRAME OF THIS STUDY WAS: OCTOBER 2019 TO FEBRUARY 2022. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: SOLITAIRE STENT RETRIEVER. AMONG PATIENT ADVERSE EVENTS INCLUDED:      ¿ SYMPTOMATIC INTRACRANIAL HEMORRHAGE: 2 PATIENTS IN THE SOLITAIRE GROUP.      ¿ PROCEDURE-RELATED AND/OR DEVICE-RELATED SERIOUS ADVERSE EVENTS: 37 PATIENTS (22.2%) IN THE SOLITAIRE GROUP, INCLUDING 2 PERFORATION, 1 DISSECTION, 2 EMBOLIZATION TO NEW TERRITORY, 2 ACCESS SITE COMPLICATIONS, AND 1 MORTALITY.      ¿ EVIDENCE OF NEW INFARCT OUTSIDE THE ORIGINAL AT-RISK TERRITORY: 4 PATIENTS (2.4%) IN THE SOLITAIRE GROUP.      ¿ EVIDENCE OF CAROTID DISSECTION OR COMPLETE CERVICAL OCCLUSION: 1 PATIENT (0.6%) IN THE SOLITAIRE GROUP.      ¿ ANY INTRACRANIAL HEMORRHAGE AT 24 HOURS: 65 PATIENTS (38.9%) IN THE SOLITAIRE GROUP. IT WAS NOTED THAT THERE WERE NO OBSERVED DEVICE DEFICIENCIES THAT COULD HAVE LED TO DEVICE-RELATED OR PROCEDURE-RELATED SERIOUS ADVERSE EVENTS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537112 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other SEE H11...