BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 25321735 · Received May 28, 2026

    Report

    Report Number
    2029214-2026-00979
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 25, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    UDI-DI
    00763000927363
    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

    CONTINUATION OF D10: REACT 71 CATHETER PRODUCT ID REACT-71 (LOT: D043003);  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 A REACT 71 CATHETER DID NOT EFFECTIVELY REMOVE A THROMBUS AND A SOLITAIRE FR (SFR) DEVICE FRACTURED DURING DELIVERY. DURING AN EMERGENCY THROMBECTOMY, THE OPERATOR INITIALLY ATTEMPTED ASPIRATION USING A REACT71 CATHETER, BUT THE ASPIRATION WAS UNSUC CESSFUL. A PHENOM27 MICROCATHETER (LOT 232175575) WAS THEN USED TO DELIVER AN SFR-6-30 THROMBECTOMY STENT FOR CLOT RETRIEVAL. DURING DELIVERY OF THE STENT, IT WAS NOTED THAT THE STENT SUDDENLY FRACTURED WITHIN THE MICROCATHETER. THE ENTIRE SYSTEM WAS SUBSEQUENTLY WITHDRAWN. IT WAS FOUND THAT THE MID-SEGMENT OF THE STENT PUSH ROD HAD FRACTURED. THE MICROCATHETER WAS REMOVED, AND PART OF THE STENT PUSH ROD WAS WITHDRAWN TOGETHER WITH THE MICROCATHETER, WHILE THE DISTAL END OF THE STENT REMAINED WITHIN THE REACT71. A NEW REACT71 AND SFR-6-30 WERE THEN USED TO REPEAT THE THROMBECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD NO ADVERSE REACTIONS AFTER THE PROCEDURE AND WAS RETURNED TO THE WARD THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243257 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 D057194 00763000927363

    Patients

    Seq Age Sex Outcome Treatment
    1