BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 21561768 · Received March 10, 2025

    Report

    Report Number
    2029214-2025-00603
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    March 4, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    UDI-DI
    00847536026896
    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

    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: PRODUCT ID: SFR-6-30 (D002065). 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE THE RESISTANCE WAS IN THE PROXIMAL SECTION OF THE CATHETER. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIOSN FOR USE (IFU). THERE WAS NO DAMAGED OBSERVED TO THE SOLITAIRE OR REBAR AFTER REMOVAL. THERE WAS NO VASOSPASM OR ATHEROSCLEROSIS IN THE VESSEL PROXIMAL TO THE THROMBECTOMY SITE.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE FR STENT RETRIEVER THAT HAD RESISTANCE DURING DELIVERY IN A REBAR MICROCATHETER. THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT BASILAR ARTERY ISCHEMIC STROKE. THE PATIENT'S BASELINE MRS WAS 4, NIHSS WAS 17, AND TICI WAS 1. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED. PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). WHEN THE SOLITAIRE WAS INSERTED IN THE MICROCATHETER FOR THE FIRST TIME, IT REACHED THE INTENDED THROMBECTOMY LOCATION AND THE FIRST PASS WAS SUCCESSFUL. WHEN PREPARING THE DELIVERY THE SECOND TIME, THE SOLITAIRE COULD ONLY BE ADVANCED A SHORT DISTANCE AND THEN COULD NOT BE DELIVERED. IT WAS NOTED THAT THE VESSEL WAS NOT TORTUOUS. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE SOLITAIRE WAS REPLACED WITH ANOTHER SOLITAIRE OF THE SAME MODEL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. TWO PASSES TOTAL WERE MADE IN THE THROMBECTOMY PROCEDURE. STROKE ONSET TO REPERFUSION TIME WAS 6.5 HOURS. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. POST-PROCEDURE TICI 3 WAS ACHIEVED, INDICATING REVASCULARIZATION; MRS IMPROVED TO 3, AND NIHSS IMPROVED TO 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197398 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5082-145 B660502 00847536026896

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male SEE H11.