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

Model Number	APB-2.5-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that on (b)(6) 2025, the physician performed a surgical procedure to treat a right internal carotid artery posterior communicating segment aneurysm.Using an echelon 10 microcatheter, the first coil was deployed to form a hoop, and subsequent coils were then inserted.When using the apb-2.5-6-3d-es coil (lot number 229582681), when preparing for hydration, the coil did not advance smoothly when being pushed through the introducer sheath.The surgeon suspected a problem with the coil and replaced it with a different model.The procedure was completed successfully, and a product complaint was filed regarding the coil.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.The patient was undergoing surgery for treatment of a saccular, ruptured right internal carotid artery aneurysm in the posterior communicating segment with a max diameter of 4mm and a 2mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information was received stating that the cause of the resistance was not determined.A continuous saline flush was admin istered and maintained as indicated in the ifu.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
This event is reported at this time based on analysis results which indicated a reportable event.H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83361) as found condition: the axium prime device was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The echelon-10 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the axium prime pusher was found broken at the break indicator with the release wire retracted.The pusher was also found with multiple bends and kinks throughout the length of the pusher.The axium prime implant coil was already detached.The implant was found stretched and damaged with the polypropylene filament unbroken.Testing/analysis: the axium prime implant coil tip od (outer diameter) was measured and found to be 0.0110¿ which is within specification (specification: 0.0108¿ +.0010¿/-.0020¿).The introducer sheath id (inner diameter) could not be measured as it was not returned.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed as the damages found is consistent with resistance.The implant coil was found damaged/stretched and the pusher was found damaged/broken.There were no reported issues pushing the axium prime implant coil from within the introducer sheath during hydration per ifu.Therefore, it is possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv/sheath not fully seated within the hub) subsequently causing the implant coil to become stuck.Advancing the coil against resistance would result in damage to the implant and pusher.The pusher was found broken and the release wire was retracted, detaching the implant as expected by the detachment subassemblies.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: 24563020
• Report Number: 9617601-2026-01727
• Device Sequence Number: 12968845
• Product Code: KRD
• UDI-Device Identifier: 00763000313715
• UDI-Public: (01)00763000313715(17)270902(10)229582681
• 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): 03/10/2026

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-2.5-6-3D-ES
• Device Catalogue Number: APB-2.5-6-3D-ES
• Device Lot Number: 229582681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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: 58 YR
• Patient Sex: Female