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

Model Number	QC-4-12-3D
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Additional information received that the cause of the premature detachment was not determined.
Additional Manufacturer Narrative
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 during delivery of a bare axium 3d coil, when the hoop was formed in half, the coil prematurely detached.It was noted that there was coil separation/break/premature detachment.The push rod was withdrawn, and a guidewire was inserted in an unsuccessful attempt to push the remaining coil from the microcatheter into the aneurysm.The microcatheter was withdrawn, and preparations were made to secure the remaining coil with a stent, however, the coil was discovered to have been dislodged by blood flow, obstructing the vessel.A solitaire fr stent was used to remove the coil.The coil microcatheter was used to fill the aneurysm with non-medtronic coils to complete the procedure.No surgical or medicinal intervention was required, the pushwire was not bent or broken, and there was no friction or difficulty during delivery.The physician did not reposition or attempt to detach the coil and the delivery pusher was not rotated during the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of a ruptured, saccular, anterior communicating artery aneurysm with a max diameter of 3.9 mm and a 3.2 mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Continuous flush was administered during the procedure.Ancillary devices include: 6f guilding guide catheter, echelon 10 microcatheter (lot 0230805676) synchro 14 microguidewire.
Additional Manufacturer Narrative
H3: an axium implant coil was returned for analysis.The axium implant coil was returned without introducer sheath.The actuator interface, positive load indicator and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.The axium implant coil pushwire was found to be broken but retained by release wire at ~7.9cm from proximal end.The coin was found to be pulled back from lumen stop and blood residue was observed under outer jacket.The shield coil was found to be stretched.The implant coil was already detached and not returned.No other anomalies were observed.Under the microscope, the outer jacket was then removed to gain access to the coin.The coin appeared to be in good condition.The lumen stop appeared visually acceptable; however, was unable to be measured accurately.The retainer ring appeared to be damaged and was unable to be measured accurately.Based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium implant was returned with the implant already detached.It is likely that the premature detachment is due to the pushwire being broken at break indicator causing the release wire to be pulled back and detachment of implant coil.Other possible causes for premature detachment are tortuous anatomy and the coil not being retracted in a one-to-one motion with the implant pusher during repositioning.The root cause could not be determined.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): 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: 22998444
• Report Number: 9617601-2025-01369
• Device Sequence Number: 8806676
• Product Code: KRD
• UDI-Device Identifier: 00763000320997
• UDI-Public: (01)00763000320997(17)270902(10)229583323
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 11/18/2025

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: 229583323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 10/23/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/06/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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 Age: 75 YR
• Patient Sex: Male