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

Model Number	QC-2-6-3D
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that two axium coils encountered difficult placement.It was reported that the 2-6 coil was advanced but could not be placed in.It was replaced with a 2-4 coil, but the 2-4 coil sill could not be placed in.Then a 1.5 mm prime coil was used instead, and the procedure was completed successfully.The coil was implanted at the intended location.The devices did not jump during deployment and the vessel was not damaged.The tip of the catheter was under stress for the 2-4 coil, but not for the 2-6 coil, and the catheter moved during deployment.The physician rotated the 2-6 coil delivery pusher during the procedure.The aneurysm did not rupture.The reported devices and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information was received.The vessel tortuosity was normal.The patient experienced no adverse reactions related to the event.The causes or contributing factors for the difficult placement and catheter movement could not be determined.The used catheter was an echelon 10 microcatheter.
Additional Manufacturer Narrative
H3: product analysis equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): two axium implant coils were returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within their opened axium implant coil inner pouches and within separate dispenser tracks.The echelon micro catheter used during the event was not returned.The axium implant coils were returned within their introducer sheaths.Visual inspection/damage location details: (pli-10) no bends or kinks were found with the axium implant coil pushwire.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.(pli-20) no bends or kinks were found with the axium implant coil pushwire.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.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿difficult placement/positioning¿ could not be confirmed.Possible contributing factors to ¿difficult placement/positioning¿ include catheter kick back and catheter tip under stress.The customer reported catheter tip was under stress.It is likely catheter tip under stress contributed to report of ¿difficult placement/positioning¿.The root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿catheter kick back¿ could not be confirmed.A possible contributing factor to ¿catheter kick back¿ is catheter tip under stress.It is likely catheter tip under stress contributed to report of ¿catheter kick back¿.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: 25672610
• Report Number: 9617601-2026-04062
• Device Sequence Number: 13376704
• Product Code: KRD
• UDI-Device Identifier: 00847536037632
• UDI-Public: (01)00847536037632(17)270228(10)228392628
• 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): 06/30/2026

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-2-6-3D
• Device Catalogue Number: QC-2-6-3D
• Device Lot Number: 228392628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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