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	Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil prematurely detached and encountered resistance.The patient was undergoing surgery for treatment of a saccular, unruptured, right internal carotid artery (ica) aneurysm with a max diameter of 12 mm and a 3.5 mm neck diameter.It was noted the patient's blood flow was ordinary and vessel tortuosity was moderate.It was reported that there was a complaint that the resistance was strong when replacing the sheath with a catheter in order to insert the coil.After collecting the coil and flushing it, an attempt was made to insert it again, but it was the same as before.From the hand movement, it appeared heavy, and although there was no bending and etc.In the delivery wire, it was thought to be some kind of malfunction, so it was requested to be collected.It was confirmed that the coil was dislodged early in the vicinity of the y-connector when it was returned to the sheath.The coil and delivery wire were collected as a set.The coil was removed from the body.There were no additional surgical or medical procedures performed.There was no deformation or damage to the delivery pusher.There was resistance during delivery.There was coil damage/early dislodgement.The coil was not repositioned.There was no coil dislodgement attempted.The delivery pusher did not rotate inside the patient.There was continuous flushing during the procedure.There was no health hazard.There was no health damage to the patient.The product was not used in an infected patient.The device was prepared as indicated in the package insert.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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: 24953701
• Report Number: 9617601-2026-02605
• Device Sequence Number: 5264590
• Product Code: KRD
• UDI-Device Identifier: 00847536021105
• UDI-Public: (01)00847536021105(17)270820(10)229477267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2026

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: 229477267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 07/02/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/18/2026; 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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