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

Model Number	APB-3-4-HX-ES
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Hemorrhagic Stroke (4417); Ruptured Aneurysm (4436)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
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
It was reported that during a procedure to treat a ruptured saccular aneurysm located at the a1-a2 segment of the right anterior cerebral artery, bleeding from the ruptured aneurysm occurred.The first coil was implanted without complications; however, when the second coil was implanted, tension developed, displacing the microcatheter and causing rupture of the aneurysm, which resulted in hemorrhagic stroke and active bleeding.The bleeding was stopped by completing implantation of the coil and placing three additional coils.Heparin was reversed, and imaging controls were performed to confirm sealing of the aneurysm.The patient experienced temporary injury, with prognosis reserved due to pre-procedure bleeding.The aneurysm max diameter was 4mm, and the neck diameter was 3mm.The patient's blood flow was normal, and the vessel tortuosity was minimal.The devices were prepared according to the instructions for use (ifu).Ancillary devices included an sl-10 microcatheter, synchro guidewire, terumo 8f sheath, neuron 088 and sofia 6fr guide catheters.
Additional Manufacturer Narrative
Update b5 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.The cause of the catheter displacement was determined to be tension in the microcatheter.There was significant tension because, upon reaching the aneurysm with the coil, the system felt so rigid that the coil would not deploy within the aneurysm, generating tension.During the initial ascent, no friction was felt; the tension was experienced when the coil reached the distal segment.

• 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: 23945405
• Report Number: 9617601-2026-00016
• Device Sequence Number: 18100282
• Product Code: KRD
• UDI-Device Identifier: 00763000313951
• UDI-Public: (01)00763000313951(17)280603(10)231446974
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151447
• 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): 02/10/2026

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-3-4-HX-ES
• Device Catalogue Number: APB-3-4-HX-ES
• Device Lot Number: 231446974
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 06/03/2025
• 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: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 70 KG