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-1.5-2-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil failed to detach.The patient was undergoing surgery for treatment of an arteriovenous malformation or arteriovenous fistula.The lesion grade was iib.The lesion was not located in the functional area of the brain (eloquent area).It was noted the patient's blood flow was ordinary and vessel tortuosity was moderate.It was reported that the patient underwent a cavernous sinus dural arteriovenous fistula transvenous embolization (cs d-avf tve).The physician approached the cavernous sinus (cs) via inferior petrosal sinus (ips) and went into sinus packing.Successful packing was achieved with 15 coils, and backflow was almost eliminated; however, the subject product was selected as the final coil.The placement was completed and tried to detach, but could not.The delivery wire was broken, but it could not be detached, so it was collected slowly.It was finished when the product was recovered successfully.There was poor dislodgement.The physician attempted to detach the coil using the instant detacher several times.The physician did not attempt to withdraw using another instant detacher.There was 1 attempt of manual dislodgement through the hypotube.There was no health damage to the patient.The product was used in an infected patient.The device was prepared as indicated in the package insert.Ancillary devices include a fubuki 5f guide catheter, a sl-10 microcatheter, and a syncro guidewire.
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.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report as the devices the customer discarded the devices.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 reporting that it was unknown if there were any causes or contributing factors for the event identified.Prior to coil non-detachment there were no issues encountered.

• 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: 24506867
• Report Number: 9617601-2026-01578
• Device Sequence Number: 16056190
• Product Code: KRD
• UDI-Device Identifier: 00847536021143
• UDI-Public: (01)00847536021143(17)270407(10)228629809
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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-1.5-2-3D-ES
• Device Catalogue Number: APB-1.5-2-3D-ES
• Device Lot Number: 228629809
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 04/07/2024
• 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