MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-4-12-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil failed to pass through the echelon 10 hub.The implant coil pushed smoothly out from the introducer sheath.There was no damage to the catheter and coil.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.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the internal carotid artery with a max diameter of 5mm and a 2mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information received reported the procedure was completed by switching to another axium.Continuous catheter flush was administered during the procedure.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the axium device was returned for analysis within a shipping box, within plastic wrap, within an opened axium device outer carton, and within an opened axium device inner pouch.Damage location details: the axium device was returned without the introducer sheath.The pushwire was found to be broken with the actuator interface and break indicator not returned.The pushwire was also found to be bent at ~137.2cm from the broken end (proximal end).The axium implant coil was returned stretched and damaged, although still attached to the pushwire.In addition, the implant coil polypropylene filament was found to be intact with the detachable element.No other anomalies were observed.Testing/analysis (including sem reports): the axium implant coil could not be tested in-house due to its damaged condition.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.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22207540
• Report Number: 2029214-2025-01375
• Device Sequence Number: 20521923
• Product Code: KRD
• UDI-Device Identifier: 00763000320997
• UDI-Public: 00763000320997
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QC-4-12-3D
• Device Catalogue Number: QC-4-12-3D
• Device Lot Number: 229583286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/13/2025
• Date Device Manufactured: 08/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown