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

Model Number	QC-4-10-HELIX
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
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
Medtronic received a report that the patient was undergoing treatment of a saccular, unruptured left posterior communicating artery segment of internal carotid artery aneurysm with a max diameter of 6.3mm and a 4.2mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that when the surgeon was performing coil filling of the aneurysm, the surgeon found that the axium coil did not move under fluoroscopy and suspected that it was accidentally detached.After withdrawing it from the body together with the microcatheter, the surgeon found that the coil was stretched.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.
Event or Problem Description
Additional information was received stating that the catheter was removed and a new spring coil replaced the axium.The cause of the premature detachment was not determined.The cause of the stretch was not determined.No issues resulted in the damage that was found.No detachment attempts (instant detacher or manual method) were made.No kink/damage was observed¿on the pushwire.The catheter used was an echelon 10 microcatheter, lot number unknown.
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.
Additional Manufacturer Narrative
B5.Updated with additional information received.H3.Product analysis: equipment used: vis m-81805, 203cm ruler m-83360 as found condition: the axium device was returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, and within a dispense coil.Visual inspection/damage location details: the actuator interface was found securely attached to the pushwire coupler tube.The break indicator was found undamaged.There was no evidence of detachment attempts found at these locations.The pushwire was found bent at ~135.5cm and bent at ~154.6cm from the proximal end.The coin was found to be undamaged and found against the lumen stop.The shield coil was found to be in good condition.The axium implant coil was found to be damaged; however, it was still attached to the pushwire.No other anomalies were observed.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" could not be confirmed; however, this event could not be ruled out.The implant coil was found to be attached to the pushwire detach element.The report notes that ¿no detachment attempts (instant detacher or manual method) were made¿.This was able to be verified as no damage or irregularities were found at these locations.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The reported echelon-10 microcatheter was not returned; therefore, any contribution the catheter had towards the ¿premature detach¿ was unable to be assessed.It was noted that the patient's blood flow and vessel tortuosity were both found to be normal.Based on the analysis performed, the customer report of ¿coil stretched" was not able to be confirmed; however, the implant was found damaged and the pusher was found bent.It is possible the implant became damaged due to advancing against resistance or due to handling/return to medtronic as the device was returned without its protective introducer sheath.H6.Coding updated based on analysis results.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 confirmed there was no issue with the echelon microcatheter.

• 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: 22460404
• Report Number: 9617601-2025-00603
• Device Sequence Number: 8826806
• Product Code: KRD
• UDI-Device Identifier: 00847536037397
• UDI-Public: (01)00847536037397(17)270210(10)228268584
• 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,Followup
• Report Date (Section B): 09/04/2025

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-4-10-HELIX
• Device Catalogue Number: QC-4-10-HELIX
• Device Lot Number: 228268584
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 08/25/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/07/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Female