MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-2-3D-ES
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
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 the axium coil was prematurely detached and escaped to the distal end.The patient was undergoing surgery for treatment of a saccular, ruptured anterior communicating artery aneurysm with a max diameter of 3mm and 2mm neck diameter.It was noted the patient's blood flow was high and vessel tortuosity was moderate.It was reported that when the surgeon used the ev3 coil to treat anterior communicating artery aneurysm, the surgeon used a 2*2 3d coil.After the coil was delivered into the aneurysm, the surgeon was preparing to adjust the position of the coil.The coil was accidentally detached.When the surgeon continued to deliver the next coil, the coil inside the aneurysm escaped to the distal end.The coil was not implanted at the intended location and there was no action/treatment plan to secure the coil.The pushwire was neither bent nor broken.There was no friction or difficulty during delivery.The physician repositioned the coil only one time, and they did not attempt to detach the coil.During the procedure, the delivery pusher was not rotated, and the continuous flush was not administered.There was no surgical or medicinal intervention required.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.Ancillary devices include a stryker guidewire.
Event or Problem Description
Additional information was received that the coil escaped far away and was not treated.The surgeon could not determine specifically which coil escaped.The cause of the coil premature detachment and migration was not determined.There were 3 coils implanted before and after the malfunctioned coil.The patient has not received any medical/surgical intervention as a result of the migration and no antiplatelet regimen was administered.
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.

• Brand Name: AXIUM PRIME BRPL 3D
• 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: 21987175
• Report Number: 9617601-2025-00453
• Device Sequence Number: 4477959
• Product Code: KRD
• UDI-Device Identifier: 00763000313678
• UDI-Public: 00763000313678
• 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: 2025
• 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): 05/21/2025

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 Expiration Date: 08/30/2026
• Device Model Number: APB-2-2-3D-ES
• Device Catalogue Number: APB-2-2-3D-ES
• Device Lot Number: 227265426
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 08/30/2023
• 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
• Patient Weight: 70 KG