BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 24203409 · Received January 28, 2026

    Report

    Report Number
    9617601-2026-00742
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 23, 2026
    Report Date
    February 4, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    KRD
    UDI-DI
    00847536021228
    PMA / PMN Number
    K203432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    UPDATE TO H6: FOLLOWING NEW INFORMATION RECEIVED, ONLY FDD A040611 NOW APPLIES TO THIS EVENT. REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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 AN AXIUM COIL BECAME HARD RAPIDLY AND HAD EXTENSION TO THE EMBOLIZATION COIL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY (A-COM) WITH A MAX DIAMETER OF 4.5MM AND A 3.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS NO ABNORMALITIES. IT WAS REPORTED THAT, "THE 3RD PRIME COIL THAT WAS INSERTED WAS ABOUT 1 CM AWAY AND BECAME HARD RAPIDLY, SO IT WAS COLLECTED. IT IS PRESUMED TO BE BROKEN." IT WAS NOTED THAT THERE WAS COIL EXTENSION TO THE EMBOLIZATION COIL AND THE COIL WAS NOT REPOSITIONED. THERE WAS NOT RESISTANCE DURING THE PREPARATIONS OR USE. THE DEVICE WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. THE EVENTS THE PRODUCT WAS NOT USED IN AN INFECTED PATIENT. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A RIST 6F GUIDING CATHETER, PHENOM17 MICROCATHETER, AND A NON-MEDTRONIC (SYNCHRO) GUIDEWIRE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT IS PRESUMED TO BE DUE TO UNRAVELLING. THE PHRASE "BECAME HARD RAPIDLY" DOES NOT INDICATE A DEVICE ISSUE SUCH AS BREAKAGE, RESISTANCE, OR SEPARATION. THE STATEMENT "PRESUMED TO BE BROKEN" REFERS TO A PRESUMED UNRAVELLING OF THE COIL. NO RESISTANCE WAS NOTED IN THE CATHETER, AND THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. NO PARTICULAR KINK OR DAMAGE WAS OBSERVED ON THE COIL OR THE CATHETER AFTER REMOVAL, AND THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE FOUND. NO DETACHMENT ATTEMPTS WERE MADE. NO KINK OR DAMAGE WAS OBSERVED ON THE PUSHWIRE. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS BY PLACING ANOTHER COIL, AND THE SAME CATHETER WAS CONTINUOUSLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266185 AXIUM PRIME BRPL 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MEDTRONIC MEXICO S. DE R.L. DE CV APB-3-4-3D-ES 227626118 00847536021228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown