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

Model Number	APB-1-2-3D-ES
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil pushwire proximal segment was kinked/ broken.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the middle cerebral artery with a max diameter of 2 mm and a 1 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the physician manually broke the coil (i.E.Did not use the instant detacher).They bent the implant delivery pusher just distal to the hypotube break indicator.He continued bending and straightening the pusher until the pusher tubing opened, but the release element was not visible.The implant delivery pusher was not there to pull.He looked closer, and there was about 1mm to grab.He pulled back on the implant pusher, while making sure the coil didn't move and was able to remove the pusher completely, with the coil implanted and intact.There was no friction or difficulty during delivery.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed per the ifu.No patient symptoms or complications were associated with this event.Additional information was received stating that the cause of the event was not determined.There were no issues that resulted in the damage that was found.The information is confirmed by the physician.Additional information was received.There was no break or separation observed with the coil or pusher.Aside from the noted damage to the proximal segment of the pushwire, no other issues were reported in this event.
Additional Manufacturer Narrative
H3: product analysis as found condition- the axium prime pusher was returned within a shipping box, within a sealed tyvek biohazard pouch, and within two resealable plastic biohazard pouches.Visual inspection/damage location details: the axium prime pusher was found kinked proximally to the break indicator.The pusher was found broken distal to the break indicator with the release wire also broken/damaged at the same location.The release wire was found retracted mostly out of the pusher.The proximal ~5.0cm of the distal pusher segment was found kinked.The coin was found fully retracted out of the lumen stop.The shield coil was found undamaged.The implant coil was already detached and not returned for analysis.Testing/analysis ¿ the exposed release wire was retracted from within the pusher and resistance was encountered.Conclusion ¿ the customer reported manually breaking the pusher and ¿the release element was not visible.The implant delivery pusher was not there to pull¿.Customer likely is referring to the broken release wire found.Resistance was found during analysis when retracting the release wire, potentially contributing towards the release wire break.It is possible the resistance occurred due to the kinks found with the pusher.Customer reported observing 1mm of the release wire remaining, which they retracted to successfully detach the implant.The pusher kink potentially occurred due to advancing against resistance or during the attempt to break the pusher.However, customer reported no friction/difficulty during the delivery.The likely cause could not be determined.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: 24146070
• Report Number: 9617601-2026-00478
• Device Sequence Number: 21082134
• Product Code: KRD
• UDI-Device Identifier: 00847536021112
• UDI-Public: (01)00847536021112(17)280326(10)230926382
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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-1-2-3D-ES
• Device Catalogue Number: APB-1-2-3D-ES
• Device Lot Number: 230926382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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
• Patient Age: 39 YR
• Patient Sex: Female