BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL HLX

    MDR report key: 21878086 · Received April 21, 2025

    Report

    Report Number
    9617601-2025-00399
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 17, 2025
    Report Date
    June 26, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    KRD
    UDI-DI
    00847536021099
    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: SAB-6-20 (LOT: B792247); PRODUCT ID: UNK-NV-NDS2; PRODUCT ID: UNK-NV-CSS. 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 A SEALED PLASTIC BIOHAZARD POUCH, AND WITHIN AN INTRODUCER SHEATH. NO MICROCATHETER WAS RETURNED. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE ACTUATOR INTERFACE WAS FOUND SECURELY ATTACHED TO THE COUPLER TUBE. THE BREAK INDICATOR WAS FOUND INTACT. NO EVIDENCE OF DETACHMENT ATTEMPTS WAS FOUND AT THESE LOCATIONS. THE PUSHWIRE WAS FOUND TO BE BENT WITHIN THE INTRODUCER SHEATH AT 54.6CM AND WAS FOUND TO BE ADVANCED OUT OF THE INTRODUCER SHEATH AND KINKED AT 40.7CM FROM THE DISTAL END. THE COIN WAS FOUND STILL AGAINST THE LUMEN STOP. THE SHIELD COIL WAS FOUND UNDAMAGED. THE IMPLANT COIL WAS FOUND STILL ATTACHED TO THE PUSHER, WITH THE POLYPROPYLENE FILAMENT INTACT. THE IMPLANT COIL WAS FOUND STRETCHED AND DAMAGED. TESTING/ANALYSIS: N/A CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER REPORT OF ¿COIL SEPARATION/BREAK¿ COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, THE AXIUM PRIME IMPLANT COIL WAS FOUND DAMAGED/STRETCHED. IN ADDITION, DAMAGE CAN OCCUR IF THE DEVICE IS ADVANCED AGAINST RESISTANCE. THE REPORT STATES, ¿IT WAS UNKNOWN IF THERE WAS ANY FRICTION OR DIFFICULTY DURING DELIVERY OF THE COIL. IT WAS SUCCESSFULLY REMOVED ALONG WITH THE MICROCATHETER.¿. NO MICROCATHETER WAS RETURNED, NOR WERE ANY DETAILS PROVIDED; THEREFORE, COMPATIBILITY COULD NOT BE DETERMINED. THE PATIENT'S BLOOD FLOW WAS NOTED TO BE NORMAL, AND VESSEL TORTUOSITY WAS FOUND TO BE MODERATE, WHICH CAN CONTRIBUTE TO THE DAMAGE FOUND, BUT WAS UNABLE TO BE CONFIRMED. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). POSSIBLE CAUSES OF COIL STRETCHING ARE, LACK OF HYDRATION BEFORE PROCEDURE, THE USER DOES NOT MAINTAIN CONTINUOUS FLUSH, TORTUOUS ANATOMY, THE COIL IS NOT RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING, PUSHWIRE ROTATION, THE USER ADVANCES THE COIL AGAINST RESISTANCE, OR AN INCOMPATIBLE CATHETER. 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 AN AXIUM COIL WHICH BROKE AND A SOLITAIRE AB (SAB) THAT FAILED TO DETACH DURING THE SAME PROCEDURE. THE PATIENT WAS UNDERGOING A STENT ASSISTED COIL EMBOLIZATION PROCEDURE TO TREAT A VERTEBRAL ARTERY (VA) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK WIDTH WAS 4.11MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE AN AXIUM COIL WAS NOTED TO HAVE BROKEN OR DETACHED PREMATURELY. IT WAS NOTED THE PUSHWIRE WAS NOT BENT OR BROKEN. IT WAS UNKNOWN IF THERE WAS ANY FRICTION OR DIFFICULTY DURING DELIVERY OF THE COIL. IT WAS SUCCESSFULLY REMOVED ALONG WITH THE MICROCATHETER. DURING THE SAME PROCEDURE, THE SAB COULD NOT BE DETACHED DESPITE 4 ATTEMPTS. THE DETACHMENT ZONE WAS NOT AGAINST THE VESSEL WALL. DURING DETACHMENT ATTEMPTS, THE CATHETER TIP WAS THE "STANDARD OPERATING DISTANCE" FROM THE DETACHMENT ZONE. IT WAS NOTED THE DETACHMENT BOX AND DETACHMENT CABLE WERE BRAND-NEW OUT-OF-BOX. THERE WAS NO DAMAGE TO THE DETACHMENT BOX WHICH DISPLAYED AS INDICATED IN THE IFU AND A NEW BATTERY WAS USED. A 20G NEEDLE WAS USED AND PLACED IN PATIENT'S MUSCLE. THE BLACK CABLE WAS CONNECTED TO THE NEEDLE AND THE RED CABLE WAS CONNECTED TO THE PUSHWIRE. THE PUSHWIRE WAS ON A DRY, CLEAN SURFACE. THE SAB WAS ALSO 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
    1742015 AXIUM PRIME BRPL HLX DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MEDTRONIC MEXICO S. DE R.L. DE CV APB-3-8-HX-ES 225860711 00847536021099

    Patients

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