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

Model Number	APB-6-20-HX-SS
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
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 of axium coil premature detachment.The patient was undergoing surgery for treatment of a saccular, unruptured right internal carotid artery posterior communicating segment aneurysm with a max diameter of 8 mm and a 5.6 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that during treatment of the aneurysm, after the microcatheter was positioned in place, a coil was successfully filled to form a hoop.When delivering this coil, after the coil body entered the aneurysm sac, the distribution was unsatisfactory.While preparing to adjust the coil body, during withdrawal it was found that the coil had spontaneously detached within the microcatheter.Therefore, the pusher rod was withdrawn, another coil was filled, the coil within the microcatheter was advanced into the aneurysm sac, and subsequent finishing coil was filled, after which the procedure was completed.The coil remained in the patient.The coil was implanted at the intended location.There were no surgical or medicinal intervention required.There was no friction or difficulty during delivery.The physician repositioned the coil one time.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during procedure.A continuous flush was administered during the procedure.There were no patient symptoms or complications associated with this event.The device and any accessories were prepared as indicated in the instructions for use (ifu).Ancillary devices include a 6f guilding guide catheter, a echelon 10 microcatheter, and a synchro 14 guidewire.
Additional Manufacturer Narrative
B5 updated e4 updated h6 added a code for information previously reported.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 there were no causes or contributing factors for the event identified.It was confirmed that there were no detachment attempts (instant detacher or manual method) made.The echelon 10 lot number was 0230918377.

• Brand Name: AXIUM PRIME BRPL HLX
• 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: 24664321
• Report Number: 9617601-2026-01956
• Device Sequence Number: 9198445
• Product Code: KRD
• UDI-Device Identifier: 00847536038608
• UDI-Public: (01)00847536038608(17)271019(10)229927140
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/22/2026

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-6-20-HX-SS
• Device Catalogue Number: APB-6-20-HX-SS
• Device Lot Number: 229927140
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 04/28/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2024
• 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 Age: 60 YR
• Patient Sex: Female