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

Model Number	QC-2-8-HELIX
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	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis (b)(4): equipment used: vis m-81805, 203cm ruler m-83360, as found condition (condition of returned device): both axium devices and the echelon-10 microcatheter was all returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch.Visual inspection/damage location details: no introducer sheath was returned with the axium device.The pushwire was found to be broken with the release wire pulled at ~7.3cm and bent at ~180.1cm from the proximal end.The release wire was able to move freely within the introducer sheath coupler tube.The axium implant coil was found to be broken off from the pushwire subassemblies; in addition, the shield coil was found to be damaged (stretched).The axium implant coil was returned and found to be stretched and damaged upon inspection.No other anomalies were observed.Testing/analysis (including sem reports): due to the damaged condition of the axium device no resistance testing was able to be performed.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed, as the device was returned with the pushwire damaged (bent, broken), and the axium implant coil broken off from the pushwire subassemblies.The axium implant coil was returned for assessment.The damage found with the axium device is consistent with advancement against resistance; however, the echelon-10 used in the procedure was returned in good condition, with no resistance able to be reproduced during testing; therefore, possibly ruling out the microcatheter as the cause for resistance.A few other possible causes of ¿coil resistance/stuck in catheter¿ are but not limited to, tortuous anatomy and/or damage or kink to pushwire; however, the root cause for the resistance was unable to be determined.Based on the device analysis and the reported information, the customer¿s report of ¿pusher kink/damage¿ was able to be confirmed.The likely cause of the damage was determined to be caused by the user advancing the axium device against the reported resistance.The event description mentions that ¿catheter resistance was noted in the proximal segment¿, which was unable to be confirmed as no resistance was able to be reproduced with the returned echeon-10 microcatheter during testing with an in-house coil.The axium device was found to be compatible with the echelon-10 microcatheter.No mention of the patients vessel tortuosity was provided in the report.The reported devices and accessory devices were prepared as indicated in the instructions for use, and continuous flush was administered during the procedure.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
It was reported that during a hepatic artery embolization procedure, significant resistance was encountered when advancing the bare axium helix coil to the middle section of the echelon microcatheter, and the coil delivery rod kinked.Catheter resistance was noted in the proximal segment.The issue occurred with two separate coils.It was contradictorily stated that there was no friction or difficulty during testing or delivery.The patient was treated for a hepatic vascular embolism, with the microcatheter inserted via the femoral artery (diameter 10mm) to reach the lesion site.The reported devices and accessory devices were prepared as indicated in the instructions for use, and continuous flush was administered during the procedure.After the coil delivery rod kinked twice, both coils were removed, and a product from another manufacturer was used, which was successfully advanced and detached.Subsequent coil filling was performed, and the patient remained stable throughout the procedure.The surgery was completed without any reported symptoms, complications, adverse events, infections, illnesses, irregularities, or deaths.No patient complications have been reported as a result of this event.Angiography was performed after coil placement and showed dense filling.Additional information received that the spring coil did encounter resistance in the microcatheter.The delivery process meant that it could be pushed out of the catheter sheath smoothly.The cause of the event was thought to be determined as a problem with the microcatheter.The coil came out of the introducer sheath smoothly.There was no kink/damage to the catheter observed.

• Brand Name: AXIUM HELIX
• 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: 23976073
• Report Number: 9617601-2026-00074
• Device Sequence Number: 17300673
• Product Code: KRD
• UDI-Device Identifier: 00847536037304
• UDI-Public: (01)00847536037304(17)270825(10)229538937
• 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): 01/06/2026

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-2-8-HELIX
• Device Catalogue Number: QC-2-8-HELIX
• Device Lot Number: 229538937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2024
• 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 Age: 56 YR
• Patient Sex: Male