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

Model Number	QC-2-4-HELIX
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding axium coil stretch.The patient was undergoing a coil embolization procedure to treat an anterior communicating artery segment unruptured saccular aneurysm.The aneurysm max diameter was 4.3mm and the neck diameter was 3.4mm.Patient's blood flow was normal.Vessel tortuosity was moderate.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).Continuous catheter flush was administered during the procedure.During the pushing/delivery process, the axium implant coil was stretched.It was noted that there was no friction or other difficulty during testing or delivery of the coil.The physician did not reposition the coil during the procedure.The coil was removed and replaced with another manufacturer's device to continue the procedure.It was noted that the same microcatheter was used without issue to the completion of the procedure.There was no harm or injury to the patient associated with this event.Ancillary devices: cook 7f sheath, navien 6f catheter, echelon microcatheter additional information received reported that there were issues that resulted in the damage that was found, and the cause of the coil stretch was not determined.
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5 as found condition: the axium device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and within an introducer sheath.The unknown echelon 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 bent at ~122.5cm from the proximal end (figure c).The axium implant coil was found stretched and broken with the polypropylene filament broken (figures d & e).Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was confirmed.Possible causes of coil stretching include, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance or damaged catheter.Customer reported vessel tortuosity as moderate, devices were prepared per ifu, no friction was noted during test or delivery of coil, continuous flush was administered, and device was not repositioned.The likely cause could not be determined.As the unknown echelon-10 micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the coil stretching could not be determined.Customer reported that the same micro catheter successfully deployed a competitor coil after the failed event, indicative that the micro catheter is working as intended.The axium device is compatible for use with all versions of echelon micro catheters.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: 23465678
• Report Number: 9617601-2025-02480
• Device Sequence Number: 15974854
• Product Code: KRD
• UDI-Device Identifier: 00847536037281
• UDI-Public: (01)00847536037281(17)270515(10)228849861
• 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): 11/04/2025

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-HELIX
• Device Catalogue Number: QC-2-4-HELIX
• Device Lot Number: 228849861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: 62 YR
• Patient Sex: Male