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

Model Number	APB-1.5-2-HX-ES
Medical Device Problem Codes	Break (1069); Therapy Delivered to Incorrect Body Area (1508); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
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 the detachment of the axium prime bare hx coil occurred automatically without activation of the pusher rod.It was near the aneurysm.The coil was not implanted in the intended location, however, the operator observed that there was minimal impact on blood flow and decided not to retrieve the coil.No patient symptoms or complications were associated with this event.There was no surgical or medicinal intervention required.The patient was undergoing surgery for treatment of an unruptured, fusiform, middle cerebral artery aneurysm with a max diameter of 4 mm and a 3 mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There was no friction or difficulty during delivery.The pushwire was intentionally bent or broken.It is unknown if the physician repositioned the coil.The physician did not attempt to detach the coil, however, the physician rotated the delivery pusher during procedure.It is unknown if a continuous flush was administered during the procedure.There was no issue with an instant detacher; coil detachment was not attempted by using an instant detacher or manual method.
Additional Manufacturer Narrative
H6 updated-removed e2403 as e2008 was applied.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 that the pusher was not intentionally detached; however, the coil detached unexpectedly near the aneurysm, and the deployment rod did not detach.It was determined that the position of the coil had minimal impact/no significant impact on blood flow, and therefore did not attempt coil retrieval/no coil removal was performed.The patient was taken off the table.It was clarified that the pushwire was not bent or broken.Causes or contributing factors for the event were identified as a product issue.
Additional Manufacturer Narrative
B5 updated h6: deleted a0401, a0406 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: 24544997
• Report Number: 9617601-2026-01652
• Device Sequence Number: 5688531
• Product Code: KRD
• UDI-Device Identifier: 00763000313821
• UDI-Public: (01)00763000313821(17)280217(10)230592337
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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,Followup
• Report Date (Section B): 06/25/2026

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-1.5-2-HX-ES
• Device Catalogue Number: APB-1.5-2-HX-ES
• Device Lot Number: 230592337
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: Not provided; 03/25/2026; 06/19/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/17/2026; 04/22/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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: Other
• Patient Sex: Unknown