BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 23437659 · Received October 31, 2025

    Report

    Report Number
    9612501-2025-02852
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 29, 2025
    Report Date
    January 12, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDM CODE IN H6 CORRECTED TO B18. 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

    CONTINUATION OF D10: SOLITAIRE FR STENT PRODUCT ID SFR-6-30 (LOT D016279) 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

    UPDATED B5 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 WHILE ATTEMPTING TO WITHDRAW THE REBAR-27 MICROCATHETER DURING SOLITAIRE FR (SFR) STENT DEPLOYMENT FOR THROMBECTOMY, IT WAS DISCOVERED THAT THE STENT MET RESISTANCE IN THE DISTAL END OF THE CATHETER AND COULD NOT BE PUSHED OUT. THE CATHETER WAS REPLACED WITH A NEW REBAR-27, BUT THE STENT STILL COULD NOT BE PUSHED OUT. A NEW SFR OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING MIDDLE CEREBRAL ARTERY THROMBECTOMY SURGERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. STROKE ONSET TO REPERFUSION TIME WAS 200 MINUTES. IT WAS NOTED THAT THE PATIENT WAS PREVIOUSLY HEALTHY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS LOCATED IN THE MIDDLE CEREBRAL ARTERY. THE CAUSE OF THE RESISTANCE ENCOUNTERED DURING THE PROCEDURE WAS NOT DETERMINED. THE PATIENT¿S BASELINE NIHSS SCORE WAS 13, AND IT IMPROVED TO 9 FOLLOWING THROMBECTOMY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED IN ACCORDANCE WITH THE IFU. NO KINK OR DAMAGE WAS OBSERVED ON THE CATHETER, BUT KINK OR DAMAGE WAS FOUND ON THE DISTAL PORTION OF THE SOLITAIRE PUSHWIRE. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702033 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5081-153 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female SEE H11...