BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3D

    MDR report key: 23294911 · Received October 15, 2025

    Report

    Report Number
    9617601-2025-02009
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    July 4, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    KRD
    UDI-DI
    00847536037700
    PMA / PMN Number
    K081465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: AS FOUND CONDITION (CONDITION OF RETURNED DEVICE): THE AXIUM DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, WITHIN A SEALED PAPER POUCH, A DISPENSER COIL, AND WITHIN AN INTRODUCER SHEATH. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE INTRODUCER SHEATH WAS FOUND TO BE APPLIED CORRECTLY WITH THE WAVELOCK FACING TOWARDS THE PROXIMAL END OF THE PUSHWIRE. THE PUSHWIRE WAS FOUND TO BE BENT AT ~6.6CM FROM THE PROXIMAL END; IN ADDITION, THE PUSHWIRE WAS FOUND TO BE BENT WITHIN THE INTRODUCER SHEATH A ~165.4CM AND BENT AT ~173.4CM FROM THE DISTAL END. THE POLYPROPYLENE FILAMENT WAS FOUND TO BE BROKEN OFF OF THE DETACH ELEMENT, STILL INTACT WITH THE IMPLANT COIL. THE AXIUM IMPLANT COIL WAS FOUND TO BE STRETCHED, DAMAGED AND FOUND TO BE KNOTTED OUTSIDE OF THE INTRODUCER SHEATH NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): DURING TESTING, THE AXIUM IMPLANT COIL WAS UNABLE TO ADVANCE OUTSIDE OF THE INTRODUCER SHEATH; THEREFORE, THE DEVICE WAS RETRACTED FROM THE INTRODUCER SHEATH WITHOUT ANY ISSUES. THE AXIUM IMPLANT COIL TIP OUTER DIAMETER (OD) WAS MEASURED TO BE 0.0116¿, WHICH WAS FOUND TO BE WITHIN SPECIFICATION (SPECIFICATION .0112¿ +.001¿/-.0025¿). THE INTRODUCER SHEATH ID (INNER DIAMETER) WAS MEASURED TO BE .0185¿ (0.47MM), WHICH WAS FOUND TO BE WITHIN SPECIFICATION (SPECIFICATION 0.47MM +0.03MM/-0.00MM). CONCLUSION: BASED ON THE DEVICE ANALYSIS AND THE REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL RESISTANCE/STUCK IN SHEATH¿ WAS ABLE TO BE CONFIRMED. THE AXIUM DEVICE WAS RETURNED DAMAGED WITH THE IMPLANT KNOTTED. A POSSIBLE CAUSE OF ¿STUCK IN SHEATH¿ COULD HAVE BEEN CAUSED DURING PREPARATION. THE REPORT NOTES THAT ¿THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION¿. NO DAMAGE OR IRREGULARITIES WERE REPORTED AFTER THE PREPARATION. THE STRETCHED FOUND WITH THE IMPLANT COIL LOOKS LIKE THE DEVICE WAS RETRACTED AGAINST RESISTANCE, WHICH COULD HAVE HAPPENED WHEN RETRACTING THE IMPLANT COIL BACK IN THE INTRODUCER SHEATH DURING PREPARATION. THE REPORT FOLLOWS UP AND STATES ¿ THE BARE AXIUM 3D COIL COULD NOT BE PUSHED OUT OF THE PROTECTIVE SLEEVE DURING DELIVERY, WHICH WAS ABLE TO BE VERIFIED AS THE COIL FAILED TO ADVANCE OUTSIDE OF THE INTRODUCER SHEATH DURING TESTING; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. A FEW POSSIBLE CAUSES OF ¿COIL RESISTANCE/STUCK IN SHEATH¿ ARE, BUT NOT LIMITED TO, , OVERTIGHTENING OF RHV, AND IMPROPER HUBBING TECHNIQUE. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUO SITY WERE DESCRIBED AS NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). 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

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE LEFT POSTERIOR COMMUNICATING ARTERY, THE BARE AXIUM 3D COIL COULD NOT BE PUSHED OUT OF THE PROTECTIVE SLEEVE DURING DELIVERY. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 3.2 MILLIMETERS AND A NECK DIAMETER OF 2.5 MILLIMETERS. BLOOD FLOW AND VESSEL TORTUOSITY WERE DESCRIBED AS NORMAL. THE DEVICE WAS NEVER IMPLANTED AND WAS REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005088 AXIUM 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MEDTRONIC MEXICO S. DE R.L. DE CV QC-3-8-3D 228781464 00847536037700

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male