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

Model Number	APB-2-2-3D-ES
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report of axium coil detachment after non-detachment.The patient was undergoing surgery for treatment of a saccular, ruptured "comunicante" anterior aneurysm with a max diameter of 4 mm and a 3 mmneck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.The reported event occurred during normal use, i.E during the life of an implanted device; after post-op and before explant.It was reported that at the time of release of the device, the axium coil detached erratically, causing a part of it to prolapse into the left anterior cerebral artery.As a result of this event, a thrombosis of the compromised vessel occurred, generating an intraprocedural complication.As a rescue measure, a stent was implanted in order to restore blood circulation and maintain vascular permeability.The coil was stuck in the sheath and had non-detachment.The physician attempted to detach the coil with the instant detacher three times.The physician did not try to detach with another instant detacher.There was one manual method at detachment attempted via hypotube.There was no issue with the instant detacher.The device and any accessories were prepared as indicated in the instructions for use (ifu).There were no patient symptoms or complications associated with this event.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.The event did not lead to or extend patient hospitalization.There was no injury 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: 50867752
• Report Number: 9617601-2026-05745
• Device Sequence Number: 21160661
• Product Code: KRD
• UDI-Device Identifier: 00763000313678
• UDI-Public: (01)00763000313678(17)290225(10)233272620
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/23/2026

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-2-2-3D-ES
• Device Catalogue Number: APB-2-2-3D-ES
• Device Lot Number: 233272620
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 02/25/2026
• 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: 26 YR
• Patient Sex: Male