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

Model Number	QC-10-20-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	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition: the axium device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, within an opened axium inner 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 kinked at ~25.5cm from the proximal end.The axium implant coil was found severely stretched outside and within the introducer sheath with the polypropylene filament broken.The implant coil tip was still attached to the implant (implant unbroken).Testing/analysis: the axium 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 include, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damaged micro catheter, or tortuous anatomy.The customer report of ¿coil break¿ was not confirmed, but the report of ¿coil kink/damage¿ and ¿pusher kink/damage¿ was confirmed.The pusher was found kinked and the implant was found stretched.The customer did not report finding any damages during preparation per ifu; therefore, it is likely the damages occurred due to advancing against the reported resistance.Customer reported devices were prepared per ifu, and vessel tortuosity as minimal.Therefore, the root cause 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 experienced resistance in the middle of the catheter.The patient was undergoing treatment for a neurovascular abnormality.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that the axium coil got stuck in the middle of microcatheter, and could not be pushed more.When the axium coil was pulled, the tip of the coil broke.The procedure was continued with another coil.The catheter was not damaged.The coil was damaged at the pushwire distal segment.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a microcatheter: echelon 10, a guidewire: avigo, and an axium coil 9x30 3d, and an axium coil 7x30 helix.
Additional Manufacturer Narrative
Continuation of d10: product information received-echelon 10 microcatheter product id: 105-5091-150, lot d033973 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 received reported that the coil came out of the introducer sheath smoothly, and continuous catheter flush was administered during the procedure.Issues contributing to the damage that was found were reported as the coil becoming stuck and not able to be advanced further.When the coil was withdrawn, the tip frayed and broke apart.The procedure was then continued with the next coil, which went smoothly and safely.

• 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: 24055361
• Report Number: 9617601-2026-00255
• Device Sequence Number: 21187558
• Product Code: KRD
• UDI-Device Identifier: 00847536037502
• UDI-Public: (01)00847536037502(17)271219(10)230274269
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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-10-20-HELIX
• Device Catalogue Number: QC-10-20-HELIX
• Device Lot Number: 230274269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 19 YR
• Patient Sex: Male