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	11/03/2025
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 an axium prime bare 3d coil met resistance/was stuck in the sheath.The coil was being delivered during aneurysm embolization, but it could not be withdrawn from the catheter.Two attempts were made, but it still could not be pushed out.The product was replaced with a new coil to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing coil embolization surgery for treatment of an unruptured, saccular, right side c4 segment aneurysm with a max diameter of 4.4 mm and a 3.5 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
Event or Problem Description
Additional information was received.The cause of the resistance was not determined, but it occurred during delivery and was localized to the middle section of the catheter.There was no resistance noted during retraction, resheathing, or withdrawal.It was not determined whether the coil came out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.No kink or damage was found on either the coil or the catheter after removal.Information regarding whether the introducer sheath was held vertically during coil hydration was not provided.
Additional Manufacturer Narrative
Updated b5, d9 h3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event 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.
Additional Manufacturer Narrative
Product analysis as found condition (condition of returned device): an axium prime coil was returned within a shipping box; within a sealed biohazard pouch; within an opened axium prime coil inner pouch and within a dispenser track.The axium prime coil was returned within introducer sheath.Visual inspection/damage location details: no bends or kinks were found with the axium prime coil pushwire.The axium implant coil appeared to be stretched and damaged within introducer sheath.The axium prime coil was pushed out further from introducer sheath without issue for additional analysis.The implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was unable to be confirmed as the axium prime coil was pushed out from the introducer sheath without issue.It is possible insufficient preparation of the axium implant coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.The root cause was unable to be determined.There was no indication that the event was related to a potential manufacturing issue, so a device history record review is not required.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: 23479778
• Report Number: 9617601-2025-02530
• Device Sequence Number: 21457399
• Product Code: KRD
• UDI-Device Identifier: 00763000313715
• UDI-Public: (01)00763000313715(17)270826(10)229539070
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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: 229539070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 01/05/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: Female