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

Model Number	QC-12-40-3D
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis as found condition (condition of returned device): two axium implant coils and an echelon-14 micro catheter were returned for analysis within a shipping box and within a sealed biohazard pouch.Visual inspection/damage location details: due to the condition in which the axium implant coils were returned, it was unable to be determined which coil belongs to which pli.(coil 1) the axium implant coil was returned within introducer sheath.The introducer sheath was found to be kinked at middle section.The axium coil pushwire was found to be broken at load indicator, broken but retained by release wire at ~4.4cm, bent at ~46.4cm and at ~77.3cm from broken proximal end.The distal pushwire assembly was found to be separated and not returned not to include the implant coil.The implant coil was returned.The implant coil was found to be stretched, damaged and detached within the introducer sheath.The axium coil was unable to be pushed out further from the introducer sheath for additional evaluation as it was found to be stuck.No other anomalies were observed.(coil 2) the axium implant coil was returned without introducer sheath.The axium implant coil pushwire was found to be kinked at ~2.6cm, broken but retained by release wire at ~7.0cm and kinked at ~156.3cm from proximal end.The implant coil was found to be already detached and returned.The axium implant coil was found to be stretched and damaged.No other anomalies were observed.(pli-30) upon visual examination, no issues were found with the echelon-10 hub.The proximal marker band was found to be damaged.The distal marker band and distal tip were found to be separated and not returned.The tubing material of the catheter separated end exhibited stretching with jagged edges.No other anomalies were observed.Testing/analysis (including sem reports): the axium implant coils could not be used for resistance testing with in-house micro catheter due to their damaged condition.(pli-30) the echelon-10 total length was measured to be ~157.2cm.The echelon-10 usable length was measured to be ~149.3cm which is within specification.The echelon-10 micro catheter was flushed; water exited from distal tip.One in-house axium implant coil was unable to pass through the echelon-10 micro catheter distal end as the coil met resistance at damaged proximal marker band.Conclusion: based on the device analysis and reported information, the customer¿s reports of ¿pusher kink/damage¿ and ¿coil stretch¿ were confirmed.Possible contributing factors include failure to hydrate the axium implant coil prior to use, resistance in catheter and lack of continuous flush during delivery.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance during device delivery¿ was confirmed.It is likely the damage found with the returned echelon-10 micro catheter contributed to the reported resistance.Possible contributing factors to ¿catheter resistance during device delivery¿ include the use of an incompatible device, failure to prepare the ancillary devices prior to use, and insufficient catheter flush.The broken end of the catheter exhibited plastic deformation (stretching and jagged edges) which indicate that the catheter separated when exceeding the tensile strength of the tubing material.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017¿.Per axium implant coil ifu (instructions for use): ¿axium detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands.¿ therefore, the echelon-10 micro catheter was found to be compatible for use with the axium implant coil.The root cause could not be determined.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 information regarding two axium coils that had resistance and were damaged during delivery in an echelon 10 micro catheter.The patient was undergoing hepatic artery coil embolization procedure via femoral artery access.Patient's blood flow and vessel tortuosity were normal.It was reported that the devices were prepared as indicated in the instructions for use (ifu).Continuous catheter flush was administered and maintained as indicated in the ifu.The echelon microcatheter was in place at the treatment location.The first coil selected qc-12-40-3d (lot number 230184266).After the coil was prepared and hydrated, resistance was felt when advancing the coil in the middle segment of the echelon microcatheter and the middle of the pusher became kinked.The coil was removed and replaced with another qc-12-40-3d coil (lot number 230193615) which was prepped and hydrated.Again, there was significant resistance during delivery.The coil stretched in the microcatheter.The system was them replaced and the procedure was complete successfully.There was no harm or injury to the patient associated with this event.Additional information was received reporting that the coils came out of the introducer sheath smoothly.There was no kink/damage or changes in appearance observed to the echelon catheter, after removal.The operator believed that the event was caused by product quality issue.

• 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: 25009420
• Report Number: 9617601-2026-02785
• Device Sequence Number: 13304450
• Product Code: KRD
• UDI-Device Identifier: 00847536037960
• UDI-Public: (01)00847536037960(17)280110(10)230193615
• 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): 04/27/2026

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: QC-12-40-3D
• Device Catalogue Number: QC-12-40-3D
• Device Lot Number: 230193615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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: 65 YR
• Patient Sex: Male