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

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after the echelon 10 45° pre-shaped tip microcatheter was in place and ready to deliver the axium prime bare (apb)coil, resistance was encountered and it was found that the coil was stuck at the distal end of the microcatheter and could not be pushed.When the coil was withdrawn outside the body, there was also resistance.The echelon microcatheter was replaced with a non-medtronic microcatheter which successfully delivered apb coil, and the subsequent coils were filled in to complete the surgery.No patient symptoms or complications were associated with this event.The patient was undergoing coil embolization surgery for treatment of a ruptured anterior communicating artery aneurysm.It was noted the patient's  vessel tortuosity was normal.Femoral artery access vessel diameter was 10 mm.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).Ancillary devices included 8f guilding guide catheter and synchro 14 guidewire.
Additional Manufacturer Narrative
Continuation of d10: echelon 10 45° pre-shaped tip microcatheter, product id 145-5091-150 (0230742548).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 reporting that the lesion characteristics were anterior communicating artery, approximately 3 mm, ruptured aneurysm.The cause of the resistance was not determined.The coil came out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.There was no kink/damage to the coil or catheter observed after removal.
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: 23382836
• Report Number: 9617601-2025-02223
• Device Sequence Number: 4863498
• Product Code: KRD
• UDI-Device Identifier: 00763000313739
• UDI-Public: (01)00763000313739(17)280215(10)230592296
• 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,Followup
• Report Date (Section B): 11/24/2025

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 Model Number: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: 230592296
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/24/2025
• Date Device Manufactured: 02/15/2025
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 52 KG