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

Model Number	APB-2-4-HX-ES
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information received that the catheter is an echelon 10.
Additional Manufacturer Narrative
B5: additional information added to event summary.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 an axium coil that; encountered resistance, became stuck in the catheter, had pre-mature detachment, and was damaged.The patient was undergoing surgery for treatment of an unruptured aneurysm.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that 3x8 axium 3d coil and the 2x6 axium coil were inserted there was no problem.However, when inserting the next 2x4 axium coil it could not be pushed into the microcatheter and when the coil was removed it was detached.It was noted that the coil did become stuck in the catheter.There was no reported catheter damage, but there was damage to the coil.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a non-medtronic 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.
Additional Manufacturer Narrative
H2/h3: product analysis as found condition: the axium prime device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, within an opened axium prime outer carton, within an opened axium prime inner pouch and within a dispenser coil.The echelon-10 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found still securely within the coupler tube.The break indicator was found undamaged.No evidence of detachment attempts was found at these locations.No damage or irregularities were found with the axium prime pusher.The coin was found still against the lumen stop.The shield coil was found undamaged.The detach element was found still attached to the pusher.The axium prime implant coil was found separated/broken from the detach element at the coil shell weld.The implant was not returned for analysis.Testing/analysis: the axium prime device could not be used for resistance testing due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed as the damages found is consistent with resistance.Possible causes for coil resistance in catheter include, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damaged micro catheter, or tortuous anatomy.The customer report of ¿coil kink/damage¿ and ¿premature detach¿ were confirmed.The cause of the premature detachment was due to the coil break.It is possible damage occurred due to advancing/retracting against the reported resistance.Customer only asserted the devices were prepared per ifu.Therefore, the root cause could not be determined.As the echelon-10 micro catheter used in the event was not returned for analysis, any contribution of the echelon-10 micro catheter towards the resistance and coil break could not be determined.The axium prime coil is compatible for use with the echelon-10 micro catheter.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: 24270623
• Report Number: 9617601-2026-00986
• Device Sequence Number: 10021743
• Product Code: KRD
• UDI-Device Identifier: 00763000313883
• UDI-Public: (01)00763000313883(17)280513(10)231350519
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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-2-4-HX-ES
• Device Catalogue Number: APB-2-4-HX-ES
• Device Lot Number: 231350519
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 02/12/2026; 03/24/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/09/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 72 KG