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

Model Number	APB-3-10-HX-ES
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	11/19/2025
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding an axium coil that had resistance in the microcatheter during delivery and detached prematu rely.It was reported that the device was prepared as indicated in the instructions for use (ifu).The device was flushed continuously during the procedure.During delivery of the coil, there was resistance at the middle section of the microcatheter.When the coil was pulled back, it detached prematurely.The coil and microcatheter were retrieved the procedure was completed without any further issue.There was kink/damage to coil pushwire.There was no impact to the patient and the blood vessel flow was normal.
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 stating that the lesion involved a small aneurysm of the internal carotid (ic) artery.Vessel tortuosity was normal.The procedure was completed without any problems, and the coil came out of the introducer sheath smoothly.The catheter used was a product from another company, not medtronic.No detachment attempts, either with the instant detacher or manual method, were made.The coil was not implanted.
Additional Manufacturer Narrative
H3: product analysis as found condition: the axium prime device was returned for analysis within a shipping box and within two resealable plastic biohazard pouches.The unknown non-medtronic micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the three tack welds were found broken with the release wire retracted.The axium prime pusher was found bent/kinked at ~5.3cm and ~7.2cm from the proximal end and at ~34.9cm and ~29.3cm from the distal end.The axium prime implant coil was found already detached and damaged.Testing/analysis: the axium prime coil 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 are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damaged micro catheter, incompatible micro catheter, or tortuous anatomy.The returned axium prime coil was found damaged, the pusher was found bent/kinked, and the tack welds were found broken.The customer did not report any issues or damages found during preparation per ifu; therefore, it is possible the damages occurred due to advancing/retracting against the reported resistance.The root cause could not be determined.It is likely the customer report of ¿premature detach¿ was due to the broken tack welds, causing the release wire to retract, detaching the implant as expected by the detachment subassemblies.As the unknown micro catheter used in the event was not returned for analysis, any contri bution of the micro catheter towards the resistance could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.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: 23740797
• Report Number: 9617601-2025-03246
• Device Sequence Number: 8421258
• Product Code: KRD
• UDI-Device Identifier: 00847536021105
• UDI-Public: (01)00847536021105(17)270820(10)229477245
• 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): 01/28/2026

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-3-10-HX-ES
• Device Catalogue Number: APB-3-10-HX-ES
• Device Lot Number: 229477245
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 01/14/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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: Unknown