BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 22340699 · Received June 26, 2025

    Report

    Report Number
    2029214-2025-01470
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    March 15, 2025
    Report Date
    August 22, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    UDI-DI
    00847536018556
    PMA / PMN Number
    K113455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE SOLITAIRE FR REVASCULARIZATION DEVICE WAS RETURNED FOR ANALYSIS. THE REBAR-27 MICRO CATHETER USED DURING THE EVENT WAS NOT RETURNED FOR ANALYSIS. THE FINGER MARKERS WERE FOUND PROPERLY ALIGNED WITHIN THE INTRODUCER SHEATH. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE PUSHER, MARKER COIL, ATTACHMENT ZONE, NON-WORKING LENGTH (TEARDROP) STRUTS, WORKING LENGTH STRUTS OR FINGER MARKERS. THE SOLITAIRE FR DEVICE WAS HYDRATED AND ADVANCED OUT OF THE INTRODUCER SHEATH WITH NO RESISTANCE ENCOUNTERED. AN IN-HOUSE REBAR-27 (MODEL: 105-5082-130 LOT: 9508614) WAS SELECTED FOR RESISTANCE TESTING. THE SOLITAIRE FR DEVICE WAS INSERTED INTO THE REBAR-27 HUB, THROUGH THE MICRO CATHETER BODY, AND OUT THE DISTAL END WITH NO RESISTANCE ENCOUNTERED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿KINK/DAMAGED¿, ¿RESISTANCE DURING DELIV/RETRIEVAL¿, AND ¿STENT STUCK IN CATHETER HUB¿ WERE NOT CONFIRMED. NO DAMAGES WERE FOUND WITH THE RETURNED SOLITAIRE FR DEVICE, AND RESISTANCE TESTING FOUND NO RESISTANCE WITH AN IN-HOUSE REBAR-27 MICRO CATHETER. AS THE REBAR-27 MICRO CATHETER USED DURING THE EVENT WAS NOT RETURNED FOR ANALYSIS, ANY CONTRIBUTION OF THE REBAR-27 TOWARDS THE FAILURES COULD NOT BE ASSESSED. THE REBAR-27 MICRO CATHETER IS COMPATIBLE FOR USE WITH THE SOLITAIRE FR REVASCULARIZATION DEVICE. 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

    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 A REPORT THAT THE SOLITAIRE FR STENT COULD NOT ENTER THE REBAR27 MICROCATHETER, AND THE STENT TIP END HAD OBVIOUS RESISTANCE. AFTER REPLACING IT WITH THE STENT OF THE SAME MODEL, THERE WAS NO SUCH PROBLEM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE PROXIMAL SECTION OF THE CATHETER. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE GUIDE WIRE AT THE TIP OF THE STENT WAS KINKED. NO DAMAGE TO THE CATHETER WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175638 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 B529877 00847536018556

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown