BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 25234746 · Received May 20, 2026

    Report

    Report Number
    2029214-2026-00930
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 20, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    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 THE PATIENT WAS UNDERGOING TREATMENT FOR MIDDLE CEREBRAL ARTERY THROMBECTOMY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE STROKE ONSET TO REPERFUSION TIME WAS 60MINUTES. IT WAS REPORTED THAT THE Y-VALVE WAS ADEQUATELY FLUSHED AND HYDRATED. THE SFR STENT WAS ADVANCED TO THE INNERMOST POSITION OF THE Y-VALVE AND INITIALLY ADVANCED SMOOTHLY INTO THE MICROCATHETER. HOWEVER, WHEN ADVANCING THE STENT TO THE MID-TO-DISTAL SEGMENT OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED, AND FURTHER ADVANCEMENT WAS NOT POSSIBLE; RESISTANCE WAS ALSO FELT DURING WITHDRAWAL. THE VESSEL WAS NOT TORTUOUS. THE STENT WAS REMOVED, AND KINKING WAS OBSERVED AT THE DETACHMENT POINT AND THE JUNCTION WITH THE STENT BODY. THE DEVICE COULD NOT BE RE-ADVANCED INTO THE MICROCATHETER. THE STENT WAS REPLACED WITH A NEW SFR, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S BASELINE WAS 9 AND POST-THROMBECTOMY CONDITION WAS 4. THERE WERE NO DAMAGES OBSERVED ON THE CATHETER AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421273 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-REBAR-27 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1