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

Model Number	APB-2.5-4-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
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
Medtronic received a report that two axium coils detachment failed.It was reported that apb-1.5-2-3d-es coil detachment failed.Backup detachment also failed.During retrieval, unintended detachment occurred, resulting in coil migration.Another coil was used apb-2.5-4-3d-es coil detachment failed.Backup detachment also failed.There was an attempt to detach via hypotube.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a non-medtronic (sl-10) 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 lesion was in the anterior cerebral artery (aca).Vessel tortuosity was normal.The patient did not experience any symptoms related to the reported axium issue.The cause of the event was not determined.More than two instant detachers (id-1-5) were used.For device apb-2.5-4-3d-es, although there was an initial non-detachment, the device was eventually detached after several attempts using the backup detachment method.For device apb-1.5-2-3d-es, the coil was also eventually detached after several attempts using the backup detachment method; however, detachment occurred at an unintended time, resulting in migration of the device to an unintended location.

• 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: 24093283
• Report Number: 9617601-2026-00326
• Device Sequence Number: 10239381
• Product Code: KRD
• UDI-Device Identifier: 00763000313708
• UDI-Public: (01)00763000313708(17)280611(10)231447133
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 02/12/2026

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-2.5-4-3D-ES
• Device Catalogue Number: APB-2.5-4-3D-ES
• Device Lot Number: 231447133
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 06/11/2025
• 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: Unknown