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

Model Number	APB-4-12-3D-SS
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2025
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 the coil did not detach with the instant detacher.Manual detachment was attempted by breaking the push wire and pulling the end, coil did not detach.While retracting the microcatheter the coil came back into the microcatheter.It was pushed back into the aneurysm with the wire.At the end there was coil protrusion into the parent vessel which was treated with neuroform atlas intracranial stent.The device and any accessories were prepared as indicated in the ifu.There was non-detachment.The physician attempted to detach the coil with the instant detacher 4 times.The physician did not try another instant detacher.There was one attempt at detachment via hypotube.Coil did not detach with the detacher or manual detachment.It was pushed into the aneurysm with guidewire and there was protrusion into the parent vessel.The patient is alive with no injury.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Ancillary devices include a sl 10 excelsior microcatheter, synchro select soft straight 0.014 guidewire.
Additional Manufacturer Narrative
B5 updated with additional information received.H6.Device codes update based on all available information.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
Additional information received clarified that while attempting to retrieve the coil, when it was only partially retracted in the mi crocatheter, it detached.Since it could not be fully retrieved safely, the physician attempt to push the coil back into the aneurysm using a guidewire but it could not be fully pushed back into the aneurysm and a portion of the coil remained outside the aneurysm, in the parent vessel.Thus a neuroform stent was implanted.The cause of premature detach after non-detachment was not determined.No issues had occurred prior to coil non-detachment.There was no damage observed to the axium pushwire.

• 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: 22945847
• Report Number: 9617601-2025-01271
• Device Sequence Number: 9819529
• Product Code: KRD
• UDI-Device Identifier: 00847536008120
• UDI-Public: (01)00847536008120(17)260901(10)227286554
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2026
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: 227286554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/09/2025
• Date Device Manufactured: 09/01/2023
• 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: 52 YR
• Patient Sex: Female