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

Model Number	APB-1-4-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an axium prime bare 3d coil met resistance and was stuck in the middle of a microcatheter.The spring coil was replaced with a new coil of the same model and size to complete the procedure.There was no damage to the microcatheter or coil.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an unruptured, saccular, left middle cerebral artery m1 segment aneurysm with a max diameter of 3.2 mm and a 1.4 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).Additional information received that the coil came out of the introducer sheath smoothly.A continuous catheter flush was administered during the procedure.The catheter was an echelon 10 microcatheter model: 105-5091-150, lot number was unknown.The cause of the resistance was not determined.Additional information received reported the same microcatheter was used to complete the procedure successfully with other coils after the complaint coil was replaced.
Additional Manufacturer Narrative
This event is reported at this time based on analysis findings which indicated a reportable event.H3.Product analysis: equipment used: vis m-81805, 203cm ruler m-83360 as found condition (condition of returned device): the axium prime device was returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, a dispenser coil, and within an introducer sheath.No microcatheter returned.Visual inspection/damage location details: the introducer sheath was found to be applied incorrectly with the wavelock facing towards the distal end of the introducer sheath.The introducer sheath was found to be in good condition.The pushwire was returned in good condition.The axium prime implant coil was found to be stretched and still attached to the pushwire; in addition, the axium prime implant coil was found to be broken in two with the distal tip not returned.No other anomalies were observed.Testing/analysis (including sem reports): due to the damaged condition of the axium prime.No resistance testing was able to be performed.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was unable to be confirmed; however, the event could not be ruled out.The damaged found with the axium prime device was consistent with ¿advancing/retracting against resistance¿.The report notes that ¿ an axium prime bare 3d coil met resistance and was stuck in the middle of a microcatheter¿.This was unable to be confirmed as the echelon-10 microcatheter was not returned for assessment.Any contribution the microcatheter had towards the resistance and/or damage was unable to be verified.The axium device was found to be compatible with the echelon-10 microcatheter.The root cause of ¿coil resistance/ stuck in catheter¿ was unable to be determined.In regards to the coil break.A few possible causes of ¿coil break/separation¿ are but not limited to coil is not retracted in a one-to- one motion with the implant pusher during repositioning and pushwire rotation.No damage was found with the axium prime pushwire.It was noted that 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); in addition, a continuous catheter flush was administered during the pro cedure.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.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: 23483222
• Report Number: 9617601-2025-02537
• Device Sequence Number: 9458708
• Product Code: KRD
• UDI-Device Identifier: 00763000313630
• UDI-Public: (01)00763000313630(17)270105(10)228012945
• 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): 11/05/2025

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-1-4-3D-ES
• Device Catalogue Number: APB-1-4-3D-ES
• Device Lot Number: 228012945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 51 KG