MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-4-10-3D
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id id-1-5 (lot: unknown); product id id-1-5 (lot: unknown); product id qc-6-10-3d (230064676).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 there was axium coil non-detachment.The patient was undergoing surgery for treatment of a saccular, ruptured internal carotid artery (ica) bifurcation branch aneurysm with a max diameter of 6 mm and a 3.5 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was severe.It was reported that the physician attempted to detach both coils using id-1-5 instant detacher multiple times.Coil did not detach.Physician used the back up method and broke the wire and pulled the suture and both coils still did not detach.The suture stretched in both cases.The physician then pulled harder and more aggressively and the coils finally released.There was coil non-detachment.The physician attempted to detach the coil with the instant detacher 3 times and an additional 3 times with a second instant detacher.There were two manual attempts at detachment via hypotube.There was no issue with the instant detacher.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.Ancillary devices include a benchmark bmk6f105, sl10 m00316890, aristotle 14 a14-200-001.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 25673369
• Report Number: 9617601-2026-04065
• Device Sequence Number: 10447587
• Product Code: KRD
• UDI-Device Identifier: 00763000845872
• UDI-Public: (01)00763000845872(17)271108(10)230064598
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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-4-10-3D
• Device Catalogue Number: QC-4-10-3D
• Device Lot Number: 230064598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 11/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 63 YR
• Patient Sex: Female