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

Model Number	APB-3.5-10-3D-ES
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
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 embolization coil extended during repositioning and another became stuck in the sheath at the microcatheter hub.The patient was undergoing coil embolization surgery for treatment of an unruptured, amorphous, internal carotid¿posterior communicating artery (ic-pc) aneurysm with a max diameter of 5.7 mm and a 4 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).A standard simple technique was used with a coil for the cerebral aneurysm.A non-medtronic 5 mm framing coil was placed.Difficulty arose in adjusting the catheter's position during implant of the axium coil, and coil unravelling occurred while inserting and retracting the coil, leading to its retrieval.The coil had been repositioned three times.There was no resistance during preparation or use and the device was flushed continuously during the procedure.When attempting to insert a second axium coil from the same lot, there was resistance and it became stuck at the sheath at the hub of the microcatheter.As a result, the coil was replaced with a product from another company, and the procedure was completed.No patient symptoms or complications were associated with this event.Ancillary devices include: stryker sl-10 microcatheter.
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
Additional information received reported that it was unknown if there were any issues that resulted in the extension/unraveling that was experienced.The introducer sheath was held vertically when the implant coil was pulled back inside during hydration.The coil had come out of the introducer sheath smoothly.A continuous catheter flush was administered during the procedure.There was damage in the proximal area of the coil.There was no kink/damage to the catheter.The cause of the resistance was said to be the damage to the proximal area of the coil.
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
Additional information was received.For the 2nd coil, it was reported that no resistance was noted in the sheath when the device was removed from the sterile pouch and prepared.However, when the coil was subsequently transferred from the introducer sheath to the microcatheter, a coil stack apparently formed at the hub, and push resistance was encountered.One possible cause is that excessive pressure was applied to the junction between the hub and the introducer sheath, creating resistance or damaging the catheter hub itself, but because the actual product could not be retrieved, the root cause remains undetermined.

• Brand Name: AXIUM PRIME BARE PL 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: 22900256
• Report Number: 9617601-2025-01176
• Device Sequence Number: 13027101
• Product Code: KRD
• UDI-Device Identifier: 00847536021273
• UDI-Public: (01)00847536021273(17)251114(10)225490354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 10/20/2025

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 Expiration Date: 11/14/2025
• Device Model Number: APB-3.5-10-3D-ES
• Device Catalogue Number: APB-3.5-10-3D-ES
• Device Lot Number: 225490354
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 09/22/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/18/2025; 10/20/2025
• Date Device Manufactured: 11/14/2022
• 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: Unknown