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

Model Number	QC-2.5-4-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the treatment of an unruptured saccular aneurysm of the anterior cerebral communicating artery, the bare axium 3d coil spring coil could not be pushed out of the protective sleeve during delivery.The device was prepared as indicated in the instructions for use (ifu).The aneurysm had a maximum diameter of 2.6 millimeters and a neck diameter of 1.8 millimeters, with normal blood flow and vessel tortuosity noted.The product was explanted and replaced.No patient complications have been reported as a result of this event.Additional information was received reporting that a continuous saline flush administered and maintained as indicated in the ifu.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): an axium implant coil was returned within a shipping box; within a sealed biohazard pouch; within a sealed tyvek biohazard pouch and within a dispenser track.The axium implant coil was returned without introducer sheath.Visual inspection/damage location details: the axium was found to be returned in two segments.The axium implant coil pushwire was found to be kinked at ~29.5cm, at ~138.9cm and broken at ~147.8cm from proximal end.The axium implant coil was found to be stretched and damaged.The axium distal ball was found to be damaged and not returned.No other anomalies were observed.Testing/analysis (including sem reports): the axium implant coil tip od (outer diameter) was unable to be measured due to its damaged condition.The id (inner diameter) of the introducer sheath was unable to be measured as it was not returned.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was unable to be confirmed as the axium implant coil was returned without the introducer sheath.It is possible insufficient preparation of the axium implant coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.The root cause was unable to be determined.There was no indication that the event was related to a potential manufacturing issue, so a device history record review is not required.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.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: 23782265
• Report Number: 9617601-2025-03395
• Device Sequence Number: 15809616
• Product Code: KRD
• UDI-Device Identifier: 00847536037656
• UDI-Public: (01)00847536037656(17)271105(10)230042819
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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-2.5-4-3D
• Device Catalogue Number: QC-2.5-4-3D
• Device Lot Number: 230042819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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: 72 YR
• Patient Sex: Female