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 Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: video inspection system (m-85519), ruler (m-83360), camera (panasonic lumix dmc-zs5 as found condition: the axium device was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The echelon-10 micro catheter used in the event was not returned for analysis.Two additional axium devices were also returned and will be addressed in pli-10 and pli-30.Visual inspection/damage location details: the pusher was found broken at the break indicator with the release wire also broken (figure e).The axium pusher was found bent at ~31.4cm from the proximal end (figure f).The coin was found still against the lumen stop (figure g).The axium implant coil was found damaged outside its introducer sheath (figure h).Testing/analysis: the axium device could not be used for resistance testing with an in-house micro catheter 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, damaged micro catheter, or tortuous anatomy.The returned axium coil was confirmed to have ¿coil kink/damage¿.The customer reported the coil came out of the introducer sheath smoothly and did not report finding damages to the coil during preparation per ifu; therefore, it is possible the damages occurred due to advancing against the reported resistance.Customer reported devices were prepared per ifu, and continuous flush was administered.Therefore, the root cause could not be determined.The pusher was found broken at the break indicator.However, the coin was not retracted out of the lumen stop; therefore, the implant did not detach.Customer did not report any detachment attempts.It is possible the pusher kinked and broke due to advancing against the reported resistance.As the echelon-10 micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be determined.However, customer reported the micro catheter was successfully used to deploy additional coils prior and after the event.(b)(6) 2025.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 for the treatment of a congenital vascular fistula, qc coil was used for filling.The access and coil was routinely hydrated and flushed.A qc-10-30-3d coil was selected to form a hoop and frame could not be pushed out of the echelon 10 microcatheter.A new qc-10-30-3d coil was then selected, which successfully pushed out and form a hoop.When the qc-3-6-3d coil was gradually filled, it could not be pushed out of the echelon 10 microcatheter.Adjustments did not improve the situation.The coil was removed and replaced with new qc-2-4-3d coil, the same problem still occurred and it could not be pushed out of the microcatheter.The qc-2-8-2d coil was then selected, which was able to push out and continue the embolization.Subsequent coils could be used normally to complete the procedure.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of complex neurovascular abnormalities.Abnormality was not located in the eloquent region.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information received reported that the cause of the resistance was said to be the coil body resistance.The resistance was in the distal part of the catheter.The coil came out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.There was kinking and entanglement of the coil.There was no kink/damage to the catheter observed.Additional information received that the qc-10-30-3d coil was kinked.

• 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: 23646452
• Report Number: 9617601-2025-02991
• Device Sequence Number: 10027507
• Product Code: KRD
• UDI-Device Identifier: 00847536037694
• UDI-Public: (01)00847536037694(17)270423(10)228735246
• 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): 11/25/2025

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: 228735246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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: Male