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	Therapy Delivered to Incorrect Body Area (1508); Material Deformation (2976); Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that axium prime bare coil embolization was started, via a non-medtronic microcatheter, from the left internal carotid to the aneurysm (an).On the first insertion, the coil was fully inserted, but deviation of one loop outside the aneurysm was observed.Because it was the first loop, about 1 cm was left inside the aneurysm, and behavior suggesting unraveling was observed, so the coil was carefully retrieved.However, complete unraveling occurred within the catheter, so the coil was retrieved as is.The product was replaced with a medtronic product to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing coil embolization surgery for treatment of an unruptured, saccular, left internal carotid aneurysm with a max diameter of 6 mm and a 4 mm neck diameter.It was noted the patient's blood flow was ordinary and vessel tortuosity was moderate.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There was no resistance during preparation or use and continuous flushing was used during the procedure.Coil extension was reported in the pusher distal region.The coil was not repositioned.Ancillary devices included headway duo microcatheter.
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 was received stating that the cause of the coil migration into the parent vessel was attributed to the neck shape of the relevant aneurysm.The causes of both the coil unraveling within the microcatheter and the pusher extension damage remain unknown.It is considered that no issues resulted in the damage that was found.The patient has not received, and will not receive, any medical or surgical intervention as a result of the coil migration.There were no changes to the antiplatelet regimen administered to the patient before or after the procedure.
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 ; 7635265677
• MDR Report Key: 23708488
• Report Number: 9617601-2025-03168
• Device Sequence Number: 10596005
• Product Code: KRD
• UDI-Device Identifier: 00847536008274
• UDI-Public: (01)00847536008274(17)271029(10)229980582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 229980582
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/26/2025
• Date Device Manufactured: 10/29/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female