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

Model Number	APB-1-3-HX-ES
Medical Device Problem Codes	Break (1069); 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	08/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: echelon 10 microcatheter model: 105-5091-150, lot no: 0228061957.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 hx coil encountered resistance, prematurely detached, and became stuck in the echelon 10 microcatheter.The patient was undergoing surgery for treatment of an unruptured, saccular aneurysm of the right internal carotid artery ophthalmic artery with a max diameter of 4 mm and a 2.4 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Continuous flush was administered during the procedure.During delivery, the coil pushed smoothly out from the introducer sheath but encountered resistance in the proximal end of the microcatheter, preventing smooth forward delivery.The delivery pusher was withdrawn to retrieve the coil.During retrieval, it was discovered that the coil had prematurely detached, leaving the coil body stuck inside the microcatheter.The microcatheter was withdrawn from the body and a water flush and 0.014 guidewire were used to push the coil to remove it from the microcatheter.The catheter was not damaged, however, coil damage was noted as "pushwire distal segment.Coil separation/break/premature detachment".The physician did not reposition or attempt to detach the coil or rotate the delivery pusher during the procedure.The coil was replaced with a new medtronic coil and was successfully delivered.No patient symptoms or complications were associated with this event.Ancillary devices included a echelon 10 microcatheter.
Additional Manufacturer Narrative
Updated b5, d9, h6 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.No kink or damage to the coil was confirmed after removal, as the information was unavailable despite communication with the customer.No kink or damage was observed on the pushwire.The cause of the resistance was not determined, and the cause of the premature detachment was also not determined.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the axium prime device was returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, a dispenser coil and within an introducer sheath.Visual inspection/damage location details: the introducer sheath was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.The pushwire was found to be broken at the break indicator.The actuator interface and release wire were both not returned; in addition, the pushwire was found to be bent within the introducer sheath at ~144.9cm and bent at ~20.1cm from the distal end.The axium prime implant coil was found to be detached.Sheild coil was found to be stretched and damaged.The coin was not returned.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed as the damages found is consistent with resistance.The axium prime device was returned with the pushwire broken/bent, damage to the shield coil, and the implant coil detached.The report noted that ¿during delivery, the coil pushed smoothly out from the introducer sheath but encountered resistance in the proximal end of the microcatheter, preventing smooth forward delivery.¿.No microcatheter was returned; therefore, any contribution the microcatheter had towards resistance was unable to be verified.The echelohn-10 microcatheter was found to be compatible with the axium prime device.The damage caused by advancing the axium prime implant coil against resistance, can possibly cause the pusher to break and cause the implant coil to separate.Based on the device analysis and the reported information, the customer¿s report of ¿premature detachment¿ or ¿coil separation/break¿ were able to be confirmed.The detachment was likely caused during the retracting of the implant coil against resistance within the microcatheter, leading to the pusher breaking, the release wire to retract and detaching the implant as expected by the detachment subassemblies.No report of any detachment attempts was mentioned.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 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: 22796046
• Report Number: 9617601-2025-00950
• Device Sequence Number: 15614175
• Product Code: KRD
• UDI-Device Identifier: 00763000313807
• UDI-Public: (01)00763000313807(17)261124(10)227822069
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/21/2025

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 Model Number: APB-1-3-HX-ES
• Device Catalogue Number: APB-1-3-HX-ES
• Device Lot Number: 227822069
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 09/26/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/09/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 63 YR
• Patient Sex: Male