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	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4):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 or a second shipping box, an opened axium prime outer carton, an opened axium prime inner pouch, and within an introducer sheath.No microcatheter was returned.Visual inspection/damage location details: the introducer sheath was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.The introducer sheath was found to be in good condition.The pushwire was found to be bent at ~24.7cm from the proximal end.The axium prime implant coil was found to be broken off and not returned.No other anomalies were observed.Testing/analysis (including sem reports): due to the damaged condition of the axium prime implant coil no further resistance testing was performed.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed, as the damaged found with the axium prime device was consistent with ¿advancing/retracting against resistance¿.The report notes that ¿ resistance was felt while pushing the coil into the microcatheter¿.A possible cause of ¿coil resistance/stuck in catheter¿ could been caused by the patients vessel tortuosity.The report notes that ¿the patient's blood flow was normal, and vessel tortuosity was moderate.¿.A moderate vessel tortuosity can lead to possible resistance as the device (implant coil) can run into issues like altered flow patterns ,complex wall interactions, and increased length, which can lead to possible damage (bends, stretching and breaks).A few other possible causes of ¿coil resistance /stuck in catheter¿ are but not limited to damage or kink to pushwire, lack of hydration before procedure, and incompatible catheter; however, the root cause could not be determined.No microcatheter was returned for assessment.No information or details were provided about the microcatheter used in the procedure; therefore, compatibility was unable to be determined.Any contribution the microcatheter had towards the resistance and/or damage was unable to be verified.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).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 resistance was felt while pushing the coil into the microcatheter.Healthcare provider (hcp) made another attempt and still resistance was felt.Hcp decided to use another coil of the same size from a different manufacturer and the procedure was completed.The coil was stuck in the proximal section of the catheter.The implant coil pushed smoothly out from the introducer sheath.There was no damage observed on the catheter or coil.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient is alive with no injury.The patient was undergoing surgery for treatment of a saccular, unruptured left internal carotid artery (ica) top aneurysm with a max diameter of 5mm and a 1.7mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.
Event or Problem Description
Additional information received that a continuous saline flush was administered and maintained as indicated in the ifu.The catheter was not a medtronic product.
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: 23457782
• Report Number: 9617601-2025-02470
• Device Sequence Number: 7884558
• Product Code: KRD
• UDI-Device Identifier: 00763000313739
• UDI-Public: (01)00763000313739(17)270604(10)228977031
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: 228977031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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 Sex: Male