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

Model Number	QC-2-6-HELIX
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an aneurysm coil embolization procedure to treat an unruptured saccular aneurysm in the left internal carotid artery (ica) clinoid segment, the bare axium helix coil was used.The aneurysm had a maximum diameter of 4 mm and a neck diameter of 3.8 mm.During the procedure, it was discovered that there was no coil alignment mark on the coil push rod, making it impossible to determine whether the coil could be detached.As a result, the coil was withdrawn.The patient's blood flow and vessel tortuosity were reported as normal.The product was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
H3: product analysis of (b)(4), lot #228091495 as found condition: the axium device was returned for analysis within a shipping; within a sealed plastic biohazard pouch; within an opened axium inner pouch; within a dispenser coil and within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.No damages were found with the pusher.The marker coil was found missing.The ptfe shrink jacket over the marker coil location was found intact and undamaged.The axium implant coil was found stretched within the introducer sheath with the polypropylene filament broken.Conclusion: the customer¿s report of ¿poor visualization¿ was confirmed.The cause of the poor visualization was due to the missing marker coil.As the ptfe shrink tubing was found undamaged at that location, it is unlikely the marker coil came off during use and the likely cause of the missing marker coil is due to a manufacturing issue.A dhr review will be performed.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.

• 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: 21682706
• Report Number: 9617601-2025-00291
• Device Sequence Number: 8311081
• Product Code: KRD
• UDI-Device Identifier: 00847536037298
• UDI-Public: 00847536037298
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 06/03/2025

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-2-6-HELIX
• Device Catalogue Number: QC-2-6-HELIX
• Device Lot Number: 228091495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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: 51 YR
• Patient Sex: Female