BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 24474801 · Received February 27, 2026

    Report

    Report Number
    9617601-2026-01497
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 27, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    KRD
    UDI-DI
    00763000313760
    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

    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 THERE WAS COIL PROTRUSION THROUGH THE SOLITAIRE AB STRUTS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY, POSTERIOR COMMUNICATING SEGMENT WITH A MAX DIAMETER OF 7.11MM AND A 4.58MM NECK DIAMETER. THE LANDING ZONE WAS 3.5MM DISTALLY AND 4.69MM PROXIMALLY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE OPERATOR PLANNED TO TREAT THE PATIENT'S POSTERIOR COMMUNICATING SEGMENT ANEURYSM OF THE INTERNAL CAROTID ARTERY WITH STENT-ASSISTED COIL. DURING THE PROCEDURE, THE ECHELON MICROCATHETER WAS PLACED INTO THE ANEURYSM SAC, AND THE SAB-6-20 STENT WAS SUCCESSFULLY DEPLOYED AFTER THE REBAR WAS PLACED IN PLACE. HOWEVER, DURING THE PROCESS OF DELIVERING THE COIL FOR ANEURYSM EMBOLIZATION, THE COIL REPEATEDLY MIGRATED OUT. THE OPERATOR ATTEMPTED COIL RETRIEVAL AND REPOSITIONING FOR EMBOLIZATION MORE THAN THREE TIMES, BUT THE COIL CONTINUED TO MIGRATE OUT. THE OPERATOR THEN RETRIEVED THE SAB STENT AND REDEPLOYED IT, ATTEMPTING TO IMPROVE THE BLOCKING EFFECT OF THE COIL THROUGH REDEPLOYMENT. HOWEVER, THIS STILL FAILED TO PREVENT THE COIL FROM HERNIATING INTO THE ARTERY WITH ANEURYSM. THE OPERATOR HAD TO REMOVE THE SAB-6-20 STENT AND REPLACE IT WITH AN ATLAS STENT FOR ASSISTANCE, AFTER WHICH THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, POSITIONING OR PROCEDURE. THE RHV WAS TIGHT. THE STENT WAS COMPLETELY APPOSED TO THE VESSEL WAS AND NOT KINKED. THE BLOOD FLOW RATE WAS NORMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE USED COIL WAS AN AXIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383263 AXIUM PRIME BRPL 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MEDTRONIC MEXICO S. DE R.L. DE CV APB-3.5-8-3D-ES 231590791 00763000313760

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male