BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 20909821 · Received December 11, 2024

    Report

    Report Number
    2029214-2024-02282
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    October 8, 2024
    Report Date
    December 11, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    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

    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 SFR-6-30 STENT ENCOUNTERED RESISTANCE IN THE REBAR MICROCATHETER. THE PATIENT WAS UNDERGOING A THROMBECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5MM. IT WAS REPORTED THAT AFTER THE CATHETER WAS DELIVERED TO THE DISTAL END OF THE THROMBUS, THE SFR-6-30 STENT WAS HYDRATED. WHEN IT WAS PUSHED FROM THE PROTECTIVE SHEATH INTO THE MICROCATHETER, THE RESISTANCE WAS VERY LARGE AND IT COULD NOT BE PUSHED INTO THE MICROCATHETER. AFTER REPLACING IT WITH ANOTHER MICROCATHETER, THE SURGERY WENT SMOOTHLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS RESISTANCE IN THE CATHETER HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141691 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 B554186

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male