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

Model Number	APB-3-6-HX-ES
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: instant detacher product id: unk-nv-ap-id (lot: unknown).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 prime bare coil passed through the phenom 17 microcatheter without any complications, however, when an attempt was made to release it, it did not release.Detachment was attempted twice with the release device and then manually, but it did not release.Difficult placement was reported, however, the coil was implanted at the intended location and the aneurysm did not rupture.The device jumped during deployment.There was no vessel damage, the tip of the catheter was not under stress, the tip of the catheter did not move during deployment, and the physician rotated the delivery pusher during procedure.The coil was replaced with a medtronic coil to complete the procedure.Medical or surgical intervention was not needed to prevent a permanent impairment of a function, the event did not lead to or extend patient hospitalization, and there was no injury as a result of the event.No patient symptoms or complications were associated with this event.The patient was undergoing coil embolization surgery for treatment of an unruptured, saccular, left internal carotid artery aneurysm with a max diameter of 4 mm and a 3 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
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 was received.It was clarified that the detachment was performed manually and an instant detacher was not used.The cause of the coil non-detachment, the difficulty in placement, and the coil jumping during deployment were not determined.There were two attempts made to detach the coil manually.No prior problems were observed before the non-detachment event, and no visible damage to the pushwire was observed after removal from the patient.

• 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: 24119162
• Report Number: 9617601-2026-00402
• Device Sequence Number: 5941715
• Product Code: KRD
• UDI-Device Identifier: 00763000313968
• UDI-Public: (01)00763000313968(17)280702(10)231590759
• 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,Followup
• Report Date (Section B): 05/12/2026

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-3-6-HX-ES
• Device Catalogue Number: APB-3-6-HX-ES
• Device Lot Number: 231590759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/02/2026; 05/05/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/24/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 60 KG