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

Model Number	APB-1.5-3-3D-ES
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
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 a solitaire ab had coil protrusion struts.The patient was undergoing surgery for treatment of a saccular, unruptured located on the right internal carotid artery, c7 segment aneurysm with a max diameter of 5.89mm and a 3.66mm neck diameter.The parent vessel was stated to be the right internal carotid artery measuring at 4.52mm.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that the operator planned to treat the patient¿s acutely ruptured aneurysm with a stand-alone coil embolization, a sab stent was prepared in case stent assistance was required.During the procedure, an echelon microcatheter was advanced into the aneurysm sac, and after the rebar catheter was selectively positioned, initial coil filling was performed.The coil could not be stabilized within the aneurysm; therefore, the sab stent was deployed for assistance, followed by coil delivery for aneurysm embolization.However, the coil continued to protrude and herniate into the parent artery.The operator retrieved the coil for adjustment and attempted re-embolization, but the sab stent was still unable to effectively prevent coil protrusion.After repeated attempts, the operator withdrew the sab stent and deployed an ep stent for assistance, and the procedure was completed successfully.There was coil protrusion through struts.There was no friction or difficulty during delivery.The rhv was tight and the stent that completely apposed to the vessel wall was not kinked.All device were prepared as indicated in the ifu and no patient complications were associated with this event.Ancillary devices include a react-71-115 guide catheter.Additional information was received reporting that the cause of the coil protrusion was not determined, however, it was noted that, "from the result, the coil repeatedly protruded into the parent artery." additional information received.The coil used in the event was a 1.5 mm axium prime es coil.

• Brand Name: AXIUM PRIME BARE PL 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: 25662004
• Report Number: 9617601-2026-04028
• Device Sequence Number: 21427540
• Product Code: KRD
• UDI-Device Identifier: 00763000313654
• UDI-Public: (01)00763000313654(17)280520(10)231402270
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 06/29/2026

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-1.5-3-3D-ES
• Device Catalogue Number: APB-1.5-3-3D-ES
• Device Lot Number: 231402270
• 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: 06/04/2026
• Initial Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 05/20/2025
• 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
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 72 KG