MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-6-15-3D-SS
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an axium coil encountered resistance in the echelon catheter and failed to deploy.The echelon catheter was also found kinked.The patient was undergoing aneurysm embolization for treatment of a saccular, unruptured aneurysm located in the c6 segment with a max diameter of 3.69 mm and a 3.45 mm neck diameter.The accessed vessel was the femoral artery with a diameter of 6.5 mm.It was noted the patient's blood flow was normal, and vessel tortuosity was normal.It was reported that during the aneurysm procedure, when using the echelon to deliver the axium coil, the resistance was obvious during advancement.Upon continuing to push, after it was advanced into position with difficulty, the coil could not be deployed normally.The operator suspected an echelon issue.After removing the echelon, it was found that the tip end had kinked and could not be used.After replacing with a new echelon, coil advancement was smooth; however, after reaching the target position, it still could not be detached.Subsequently, a new coil was used instead; advancement was smooth and all were successfully deployed.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.
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.

• Brand Name: AXIUM PRIME BRPL 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 ; +1(763)526-5677
• MDR Report Key: 50915621
• Report Number: 9617601-2026-05808
• Device Sequence Number: 20277911
• Product Code: KRD
• UDI-Device Identifier: 00847536038295
• 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): 09/28/2026

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: APB-6-15-3D-SS
• Device Catalogue Number: APB-6-15-3D-SS
• Device Lot Number: 230911021
• 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: 09/24/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 04/21/2025
• 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: Male