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

Model Number	APB-3-10-HX-ES
Medical Device Problem Codes	Break (1069); Therapy Delivered to Incorrect Body Area (1508); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2025
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 an axium coil prematurely detached.The patient was undergoing surgery for treatment of an unruptured cerebral aneurysm.It was reported that during an aneurysm embolization procedure using a flow diverter, the pipeline device was correctly positioned at the level of the aneurysm neck.The echelon microcatheter was properly anchored inside the aneurysm and two coils had been previously implanted without intercurrences.At the time of the attempt to implant the third microcoil, early detachment of the device was observed, before its complete and adequate accommodation inside the aneurysm.As a consequence, part of the microcoil remained inside the aneurysm, while the other part was projected out of the aneurysm neck.It is noteworthy that, during the preparation of the material, no apparent damage to the device was identified, nor was there any abnormal resistance during the removal of the microspring from the hive, followed by the instructions for use.The coil remained in the patient and was not implanted at the intended location.Faced with the early detachment of the microspring and the need to stabilize the aneurysm, it was decided to implant a stent of another brand to help fix it properly.However, the next day, when performing an imaging exam, the presence of a dislocated spring pusher in the patient's carotid artery was identified.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
Additional Manufacturer Narrative
H6: correction of codes based upon review of previously reported information and investigation completion.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 HLX
• 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: 23896821
• Report Number: 9617601-2025-03735
• Device Sequence Number: 5331765
• Product Code: KRD
• UDI-Device Identifier: 00763000313982
• UDI-Public: (01)00763000313982(17)280314(10)230910966
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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-3-10-HX-ES
• Device Catalogue Number: APB-3-10-HX-ES
• Device Lot Number: 230910966
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 03/14/2025
• 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: Female