MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-3-6-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis # (b)(4): equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5 drawing(s) referenced: n/a as found condition: the axium device was returned for analysis within a shipping box, within an unsealed plastic biohazard pouch, within a dispenser coil and within an introducer sheath.The echelon-10 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The axium pusher was found broken at the positive load indicator with the release wire retracted (figure c).The release wire was found broken/separated from the proximal pusher segment, and the proximal pusher was not returned for analysis.No other damages were found with the remaining pusher.The axium implant coil was found already detached within the introducer sheath (figures d <(><<)>(> <(>&<)><(><<)>)> e).No damages or irregularities were found with the implant coil.Testing/analysis: the axium device could not be used for resistance testing as the implant was already detached.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed.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, or tortuous anatomy.No damages were found with the returned pusher or implant that would contribute towards or indicates that resistance had occurred.The pusher was found broken at the positive load indicator, the release wire was found retracted, and the implant was found detached as expected by the detachment subassemblies.Customer did not report attempting to detach the device.Due to the location of the implant coil within the introducer sheath (about 1/6th from the distal end of sheath), it is likely the detachment occurred after the event and not due to the reported resistance within the micro catheter.The root cause of the resistance 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 could not be assessed.The axium 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.
Event or Problem Description
Medtronic received a report that the axium coil encountered resistance with the microcatheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the ophthalmic artery segment.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the axium qc coil could not be pushed into the microcatheter.During aneurysm surgery, resistance was encountered when pushing the coil into the echelon 10 microcatheter.It was reported there was coil resistance/stuck in the proximal section of the catheter.There was no catheter or coil damage observed.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Additional information was received that the cause of the resistance was not determined.The coil came out of the introducer sheath smoothly.The catheter used was an echelon 10.

• Brand Name: AXIUM 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: 22170978
• Report Number: 9617601-2025-00532
• Device Sequence Number: 9401525
• Product Code: KRD
• UDI-Device Identifier: 00847536037694
• UDI-Public: 00847536037694
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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
• Report Date (Section B): 06/09/2025

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: QC-3-6-3D
• Device Catalogue Number: QC-3-6-3D
• Device Lot Number: 227675855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2023
• 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
• Patient Sex: Male