BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 21801058 · Received April 8, 2025

    Report

    Report Number
    2029214-2025-00920
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    December 29, 2024
    Report Date
    April 8, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    PMA / PMN Number
    K151447
    Adverse Event
    Yes
    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

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY, SEVERAL COMPLICATIONS OCCURRED. THE SAB-6-30 STENT WAS USED TO ASSIST IN THE TREATMENT OF THE INTRACRANIAL ANEURYSM. DURING THE COIL FILLING PROCESS, THE INITIALLY FILLED SPRING COIL FORMED A HOOP INTACT. HOWEVER, THE SPRING COIL THEN PASSED THROUGH THE STENT AND WAS TEMPORARILY STABILIZED AFTER ADJUSTMENT. HOWEVER, AFTER DETACHMENT, WHEN THE SUBSEQUENT SPRING COIL WAS FILLED AGAIN, THE SPRING COIL PASSED THROUGH THE STENT AND EXTENDED INTO THE PARENT ARTERY, AND THEN BROUGHT OUT THE PREVIOUSLY FILLED AND DETACHED SPRING COIL. THE PATIENT SUFFERED FROM ACUTE INTERNAL CAROTID ARTERY OCCLUSION, AND HAD TO USE SAB-6-20 TO REMOVE THE THROMBUS AND COIL TOGETHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE REPLACEMENT OF THE STENT WITH AN ATLAS STENT. THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING DELIVERY, POSITIONING, OR THE PROCEDURE. THE SOLITAIRE HAD BEEN COMPLETELY APPOSED TO THE VESSEL WALL AND WAS NOT KINKED. THE RHV WAS NOTED TO BE TIGHT DURING THE PROCEDURE. THE ANEURYSM MAX DIAMETER WAS 5.66MM, AND THE NECK WIDTH WAS 4.28MM. THE LANDING ZONE WAS 3.55M DISTAL AND 5.25MM PROXIMAL. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 10 MINUTES. THE PATIENT STATUS WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE COIL PROTRUSION WAS NOT DETERMINED. THERE WAS NO DAMAGE TO THE SOLITAIRE AB OR COIL. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PREVIOUSLY FILLED/DETACHED COIL THAT WAS PULLED OUT WAS NOT A MEDTRONIC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707717 AXIUM PRIME BRPL 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-3-6-3D-ES 228781449

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention