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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
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 emergency aneurysm embolization procedure to treat a ruptured, right-side, saccular aneurysm, a coil separation/break/premature detachment occurred with the bare axium helix coil.The spring coil detached during delivery into the microcatheter and also experienced in vitro detachment, meaning it detached outside the body.The aneurysm had a maximum diameter of 3 millimeters and a neck diameter of 2.6 millimeters, with normal blood flow and minimal vessel tortuosity.No surgical or medicinal intervention was required, and a new model of the product was selected for embolization.The pushwire was not bent or broken.The physician did not reposition the coil.There was no friction or difficulty encountered during delivery.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.The continuous flush was not administered during the procedure.The patient outcome was reported as alive with no injury.
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
Additional information received that the cause of the premature detachment was not determined.
Additional Manufacturer Narrative
Product analysis #(b)(4):equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): an axium implant coil was returned for analysis within a shipping box and within a sealed biohazard pouch.The axium implant coil was returned without introducer sheath.Visual inspection/damage location details: the actuator interface, positive load indicator and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.The axium coil pushwire was found to be broken but retained by release wire at break indicator and kinked at ~160.2cm from proximal end.The coin was found to be not against the lumen stop.The implant coil was already detached and returned.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium implant coil was returned with the implant already detached; however, the root cause could not be determined.It is likely the premature detachment was due to the pushwire break at break indicator causing the release wire to be pulled back and releasing the implant coil.It is possible the damage (break/bent) to the pushwire occurred upon opening the package and attempting to remove the product or after removing it from the package and preparing it per ifu.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: 21066703
• Report Number: 9617601-2025-00015
• Device Sequence Number: 12882843
• Product Code: KRD
• UDI-Device Identifier: 00847536037281
• UDI-Public: 00847536037281
• 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,Followup,Followup
• Report Date (Section B): 03/13/2025

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 Expiration Date: 02/15/2026
• Device Model Number: QC-2-4-HELIX
• Device Catalogue Number: QC-2-4-HELIX
• Device Lot Number: 226008874
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 02/20/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/31/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: 49 YR
• Patient Sex: Male