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

Model Number	APB-2-4-3D-ES
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Paresis (1998); Foreign Body In Patient (2687); Ischemia Stroke (4418); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that a coil was broken prior to detachment attempts.No other device, event, or patient information was known at the time the report was received.
Additional Manufacturer Narrative
B3: event date is not known.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.
Additional Manufacturer Narrative
A2, a3a patient information updated b5 updated with additional information received.D2-d4 device information updated based on additional information received.E1 initial reporter/physician information updated based on additional information received h6 coding information updated based on additional information received.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 received reported the axium coil broke during positioning during the procedure.An attempt was made to remove the coil with a stent retriever without success.The patient was undergoing coil embolization to treat an anterior communicating (acom) aneurysm.The patient remained hospitalized and under sedation as of (b)(6) 2025, due to a1 segment infarct and occlusion.The patient additionally experienced left side lower extremity hemiparesis.
Event or Problem Description
Additional information was received that vessel tortuosity was normal, no excessive tortuosity.The device was prepared and a continuous catheter flush was administered and maintained during the procedure as indicated in the ifu.There was no resistance during delivery of the coil.This was the first aneurysm.It did have 2 bleps and the first blep was successfully coiled.The coil was not repositioned or pulled back.During primary placement, the coil didn¿t react to pull back.There was no kink/damage observed on the pushwire.
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 CA 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23488283
• Report Number: 2029214-2025-02341
• Device Sequence Number: 13384068
• Product Code: KRD
• UDI-Device Identifier: 00763000313692
• UDI-Public: (01)00763000313692(17)280315(10)230911474
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 02/02/2026

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-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: 230911474
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 02/02/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/21/2025; 02/02/2026
• Date Device Manufactured: 03/15/2025
• 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
• Outcome Attributed to Adverse Event: Disability; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 72 KG