BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR4

    MDR report key: 22521543 · Received July 16, 2025

    Report

    Report Number
    2029214-2025-01603
    Event Type
    Death
    Date Received
    July 16, 2025
    Date of Event
    June 8, 2025
    Report Date
    August 11, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    UDI-DI
    00763000257002
    PMA / PMN Number
    K183022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION RECEIVED INDICATED PLI30 AND PLI40 ARE NO LONGER REPORTABLE. SINCE A REGULATORY REPORT HAS BEEN SENT GCH FUNCTIONALITY DOES NOT ALLOW THE COMPLAINT FLAG TO BE CHANGED TO NO. SHOULD FURTHER INFORMATION MAKE THE EVENT REPORTABLE AGAIN THE EVENT WILL BE REOPENED AND A REGULATORY REPORT WILL BE SENT. SEE SECTION H.6. FOR CORRECTED CODES. 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID SFR4-6-40-10 (B791192); PRODUCT TYPE: PRODUCT ID 105-5081-153 (B813957); PRODUCT TYPE: PRODUCT ID 103-0606-200 (B810426); PRODUCT TYPE: 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 RECEIVED INFORMATION REGARDING A SOLITAIRE X STENT RETRIEVER (SFR4-6-40-10, LOT: B791192) THAT BROKE DURING A PROCEDURE. IT WAS REPORTED THAT PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT A NON-HEMORRHAGIC STROKE. THE SOLITAIRE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE SOLITAIRE WAS DEPLOYED FOR CLOT RETRIEVAL. HOWEVER, DURING RETRIEVAL, THERE WAS RESISTANCE IN THE DISTAL END OF THE CATHETER (REBAR, 105-5081-153, LOT: B813957) AND THE SOLITAIRE BROKE AND REMAINED IN THE CLOT. THE SURGEON USED ANOTHER SOLITAIRE X (SFR4-4-40-10, LOT: B777662) TO RETRIEVE THE BROKEN SOLITAIRE ALONG WITH THE CLOT. IT APPEARS THE BROKEN DEVICE WAS SUCCESSFULLY RETRIEVED. HOWEVER, IT WAS NOTED THAT THE PATIENT ULTIMATELY HAD AN OUTCOME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539093 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR4-4-40-10 B777662 00763000257002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death SEE H11...