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

Model Number	QC-2-4-3D
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): an axium implant coil was returned for analysis within a shipping box; within a sealed biohazard pouch and within an opened axium implant coil inner pouch.The echelon-10 micro catheter used during the event was not returned.The axium implant coil was returned within introducer sheath.Visual inspection/damage location details: the axium implant coil pushwire was found to be bent at ~65.1cm from proximal end and broken but retained by release wire at ~145.9cm.The implant coil was found to be stretched and damaged within the introducer sheath.The axium implant coil was unable to be pushed out further from the introducer sheath for additional evaluation as it was found to be stuck.No other anomalies were observed.Testing/analysis (including sem reports): the axium implant coil could not be used for resistance testing with an in-house micro catheter 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.
Event or Problem Description
Medtronic received a report that an axium coil had resistance in the microcatheter.The patient was undergoing surgery for treatment of an unruptured, saccular aneurysm with a max diameter of 3 mm and a 2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).It was reported that the spring coil had resistance in the microcatheter and couldn't be pushed out.No patient symptoms or complications were associated with this event.Additional information received reported the resistance was in the middle of the catheter.The coil came out of the introducer sheath smoothly.Continuous catheter flush was administered during the procedure.The spring coil had a kink and stretched shape.The microcatheter was not damaged.The catheter was a medtronic catheter.

• 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: 22967938
• Report Number: 2029214-2025-01967
• Device Sequence Number: 9125227
• Product Code: KRD
• UDI-Device Identifier: 00847536037625
• UDI-Public: (01)00847536037625(17)260224(10)226051944
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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 Expiration Date: 02/24/2026
• Device Model Number: QC-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: 226051944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 02/24/2023
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 81 KG