BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 20995657 · Received December 20, 2024

    Report

    Report Number
    2029214-2024-02418
    Event Type
    Death
    Date Received
    December 20, 2024
    Date of Event
    April 15, 2024
    Report Date
    December 20, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-SFR (UNKNOWN); PRODUCT TYPE: IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: LI L, LIANG Z, LIN C, CUI B, JIA Q. EFFICACY AND SAFETY OF 3-MONTH DUAL ANTIPLATELET THERAPY IN PATIENTS AFTER MECHANICAL THROMBECTOMY FOR ACUTE ISCHEMIC STROKE: A RETROSPECTIVE STUDY. FRONTIERS IN NEUROLOGY 15:1374093 2024. DOI:10. 3389/FNEUR.2024.1374093 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: 'THE EFFECTIVENESS AND SAFETY OF 3-MONTH DUAL ANTIPLATELET THERAPY (DAPT) AND 1-MONTH DAPT IN PATIENTS AFTER MECHANICAL THROMBECTOMY FOR ACUTE ISCHEMIC STROKE.' THE FOLLOWING MEDTRONIC DEVICES WERE USED: SOLITAIRE FR STENTS WERE USED FOR STENT THROMBECTOMY. DEATHS OCCURRED IN THE STUDY POPULATION: THERE WERE 11 DEATHS INCLUDED IN THE STUDY, THOUGH A SPECIFIC CAUSE OF DEATH WAS NOT REPORTED. AMONG PATIENT ADVERSE EVENTS INCLUDED: RECURRENCE OF CEREBRAL INFARCTION OCCURRED IN 11 TOTAL PATIENTS. SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) OCCURRED IN 3 TOTAL PATIENTS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328676 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SFR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death SEE H11...