BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3D

    MDR report key: 22171152 · Received June 9, 2025

    Report

    Report Number
    2029214-2025-01341
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    March 24, 2025
    Report Date
    June 9, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    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 IMPLANT COIL WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND WITHIN A SEALED PLASTIC BIOHAZARD POUCH. NO MICROCATHETER WAS RETURNED. DAMAGE LOCATION DETAILS: THE AXIUM IMPLANT COIL WAS RETURNED WITHIN AN INTRODUCER SHEATH, WHICH WAS FOUND TO BE APPLIED CORRECTLY, WITH THE WAVELOCK FACING TOWARDS THE PROXIMAL END OF THE PUSHWIRE. THE INTRODUCER SHEATH WAS RETURNED IN GOOD CONDITION. THE PUSHWIRE WAS FOUND TO BE KINKED AT ~3.6CM AND BROKEN AT ~13.2CM FROM THE PROXIMAL END (RELEASE WIRE NOT PULLED); HOWEVER, THE PUSHWIRE WAS FOUND TO BE BENT WITHIN THE INTRODUCER SHEATH AT ~12.6CM AND BENT AT ~7.8CM FROM THE DISTAL END. THE AXIUM IMPLANT COIL WAS FOUND TO BE DAMAGED WITHIN THE INTRODUCER SHEATH. IN ADDITION, THE POLYPROPYLENE FILAMENT WAS INTACT WITH THE DETACHABLE ELEMENT. THE AXIUM IMPLANT COIL WAS UNABLE TO ADVANCE OUT OF THE INTRODUCER SHEATH. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): THE AXIUM IMPLANT COIL TIP OD (OUTER DIAMETER) WAS MEASURED TO BE 0.0104¿, WHICH WAS FOUND TO BE WITHIN SPECIFICATION (SPECIFICATION 0.0112¿ +.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 +0.03M/-0.00MM). 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 ON MARCH 24, 2025, THE HEALTHCARE PROVIDER (HCP) PERFORMED TREATMENT FOR ANTERIOR COMMUNICATING ARTERY ANEURYSM. AFTER PUNCTURE, THE ECHELON10 MICROCATHETER WAS INSERTED TO THE LESION SITE. THE FIRST SPRING COIL WAS QC-3-8-3D. WHEN PREPARING FOR HYDRATION, THE SPRING COIL COULD NOT BE PUSHED OUT OF THE PROTECTIVE SHEATH. AFTER MULTIPLE ATTEMPTS, IT STILL COULD NOT BE PUSHED OUT. HCP REPLACED IT WITH THE SPRING COIL OF THE SAME MODEL, HYDRATED IT, AND FILLED THE ANEURYSM. AFTER FILLING, SELECTED THE SECOND SPRING COIL APB-2-6-HX-ES. AFTER FILLING, SELECTED TWO SPRING COILS APB-2-4-3D-ES AND APB-1-3-3D-ES SUCCESSIVELY. AFTER FILLING, PERFORMED ANGIOGRAPHY OF THE SPRING COIL, FILLED DENSELY, WITHDREW THE SPRING COIL AND MICROCATHETER, AND THE OPERATION WAS COMPLETED. THERE WAS COIL RESISTANCE/STUCK IN SHEATH. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF T HE EVENT WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. WHEN PREPARING FOR HYDRATION, IT COULD NOT BE PUSHED OUT SMOOTHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477343 AXIUM 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 QC-3-8-3D 229105931 00847536037700

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male