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

Model Number	QC-2-4-3D
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is reported at this time based on analysis findings which indicated a reportable event.H4.Product analysis: equipment used: vis m-81805 203cm rulerm -83360 as found condition (condition of returned device): the axium coil and the echelon-10 microcatheter were both returned for analysis within a shipping box, and within a sealed plastic biohazard pouch.Damage location details: no introducer sheath was returned.The pushwire was found to be broken at the break indicator, in addition the pushwire was found to be bent at ~ 26.8cm and bent at ~136.7cm from the (broken) proximal end).The axium implant was found to be detached and not returned (figure e).The shield coil was found to be in good condition.No other anomalies were observed.Testing/analysis (including sem reports): due to the damaged condition of the implant coil, no testing was able to be performed.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil stretch¿ was unable to be confirmed.The axium device was returned broken at the break indicator with the release wire pulled.No implant coil was returned; therefore, the cause of coil stretching was unable to be determined.Any contribution the implant coil had towards the report was unable to be assessed.It is possible that the damage may have been caused during the preparation, but this was unable to be confirmed.The customer noted that an axium device was stretched; however, the cause couldn¿t be verified.Possible causes for failure are, the user does not maintain a continuous flush, the coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, and user advances the coil against resistance.The cause was unable to 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 report that during an aneurysm coil embolization procedure, the micro guidewire could not pass through the echelon 10 microcatheter.The catheter was replaced to continue the procedure.During the same procedure, an axium coil was stretched; the coil was also replaced to continue the procedure.It was noted that the devices were prepared and catheter was flushed as indicated in the instructions for use (ifu).There was no harm or injury to the patient who was undergoing and coil embolization procedure via femoral access to treat an internal carotid artery (ica) unruptured saccular aneurysm.Patient's blood flow and vessel tortuosity were normal.Additional information received reported that there were no issues that resulted in the axium coil stretch.

• 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: 22539043
• Report Number: 9617601-2025-00656
• Device Sequence Number: 12738585
• Product Code: KRD
• UDI-Device Identifier: 00847536037625
• UDI-Public: (01)00847536037625(17)270118(10)228091320
• 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): 07/17/2025

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-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: 228091320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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: 66 YR
• Patient Sex: Female