BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 21807913 · Received April 9, 2025

    Report

    Report Number
    9617601-2025-00340
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    April 6, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    KRD
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID RFX058-125-08 (LOT: B760437); PRODUCT ID FA-55150-1030 (LOT: 228242112). 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

    H3: PRODUCT ANALYSIS AS FOUND CONDITION: THE AXIUM PRIME DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN AN UNSEALED PLASTIC BIOHAZARD POUCH AND WITHOUT AN INTRODUCER SHEATH. THE UNKNOWN MICRO CATHETER USED IN THE EVENT WAS NOT RETURNED FOR ANALYSIS. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE ACTUATOR INTERFACE WAS FOUND SECURELY ATTACHED TO THE COUPLER TUBE AND THE BREAK INDICATOR WAS FOUND UNBROKEN. NO EVIDENCE OF DETACHMENT ATTEMPTS WAS FOUND AT THESE LOCATIONS. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE AXIUM PRIME PUSHER. THE AXIUM PRIME IMPLANT COIL WAS FOUND STILL ATTACHED TO THE PUSHER. THE IMPLANT COIL WAS FOUND SLIGHTLY STRETCHED AND DAMAGED WITH THE POLYPROPYLENE FILAMENT UNBROKEN. THE IMPLANT COIL WAS FOUND UNBROKEN (TIP STILL ATTACHED TO IMPLANT). TESTING/ANALYSIS: N/A CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿PREMATURE DETACH¿ COULD NOT BE CONFIRMED AS THE IMPLANT WAS RETURNED STILL ATTACHED AND UNBROKEN. THE CUSTOMER REPORT OF ¿COIL STRETCH¿ WAS CONFIRMED, BUT THE CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF COIL STRETCHING ARE, LACK OF HYDRATION BEFORE PROCEDURE, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, TORTUOUS ANATOMY, COIL NOT RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING, PUSHWIRE ROTATION, USER ADVANCES THE COIL AGAINST RESISTANCE OR INCOMPATIBLE CATHETER. CUSTOMER REPORTED VESSEL TORTUOSITY AS SEVERE, DEVICES WERE PREPARED PER IFU, AND DEVICE WAS REPOSITIONED ONCE. IT IS POSSIBLE THE SEVERE VESSEL TORTUOSITY CONTRIBUTED TOWARDS THE FAILURE. AS THE UNKNOWN MICRO CATHETER USED IN THE EVENT WAS NOT RETURNED FOR ANALYSIS, ANY CONTRIBUTION OF THE MICRO CATHETER TOWARDS THE COIL STRETCHING COULD NOT BE DETERMINED. AS THE MODEL AND LOT NUMBERS WERE NOT REPORTED, COMPATIBILITY COULD NOT BE ASSESSED. 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 INFORMATION REGARDING A NAVIEN 5F INTERMEDIATE CATHETER THAT HAD RESISTANCE WITH THE MARKSMAN MICROCATHETER AND THERE WAS DAMAGE TO THE MARKSMAN MICROCATHETER AS WELL AS AN AXIUM COIL. THE PATIENT WAS UNDERGOING AN ANEURYSM EMBOLIZATION PROCEDURE TO TREAT A RIGHT CLINOID SEGMENT UNRUPTURED FUSIFORM ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3.3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CONTINUOUS CATHETER FLUSH WAS ADMINISTERED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING DELIVERY OF THE MARKSMAN MICROCATHETER IN THE NAVIEN CATHETER, THE RESISTANCE WAS RELATIVELY SIGNIFICANT IN THE DISTAL END AND IT WAS NOTED THAT THE MARKSMAN CATHETER DISTAL END WAS KINKED. BOTH CATHETERS WERE REPLACED TO CONTINUE THE PROCEDURE. DURING THE SAME PROCEDURE AN AXIUM COIL STRETCHED AND SEPARATED/DETACHED PREMATURELY DURING DELIVERY/DEPLOYMENT. IT WAS UNKNOWN IF THE COIL EXPERIENCED ANY RESISTANCE. IT WAS NOTED THAT THE PHYSICIAN REPOSITIONED THE COIL ONCE BUT HAD NOT ATTEMPTED TO DETACH THE COIL AND DID NOT ROTATE THE PUSHER. THE PUSHWIRE WAS NOT BENT OR BROKEN. NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE COIL WAS SAFELY REMOVED TOGETHER WITH THE MICROCATHETER AND WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420548 AXIUM PRIME BRPL 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MEDTRONIC MEXICO S. DE R.L. DE CV APB-3-6-3D-ES 227569906

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male SEE H11...