BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 24980854 · Received April 24, 2026

    Report

    Report Number
    2029214-2026-00728
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    April 22, 2026
    Report Date
    April 24, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 DURING THE THROMBECTOMY PROCEDURE, WHEN THE OPERATOR PREPARED TO USE A SOLITAIRE FR STENT DEVICE, AN SFR-6-30 WAS OPENED. DURING CLOT RETRIEVAL, A FRACTURE OCCURRED. THE FRACTURE OCCURRED AT THE CONNECTION POINT OF THE SFR-6-30, RESULTING IN STENT DISASSEMBLY. FORTUNATELY, THE FRACTURED PORTION HAD ALREADY BEEN PARTIALLY DRAWN INTO THE CATHETER, ALLOWING THE ENTIRE DEVICE TO BE WITHDRAWN FROM THE BODY. NO ADVERSE EVENT OCCURRED. THERE WAS SEPARATION. THE PATIENT DID HAVE VESSEL STENOSIS PROXIMAL TO THE THROMBUS SITE. IT IS UNKNOWN HOW MANY TIMES THE PUSHWIRE WAS TORQUED. TWO PASSES WERE MADE USING THIS STENT. THE MICROCATHETER TIP DID NOT COVER THE STENT PROXIMAL MARKER DURING RETRIEVAL. THE STENT WAS REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE STENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381480 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 D050601 00763000927363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown