MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM HELIX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-2-2-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	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 145-5091-150 (0226997398); implant date n/a; explant date n/a.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 an axium coil prematurely detached and the echelon catheter tip disconnected.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the cavernous sinus with a max diameter of 5mm and a 4mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.The access vessel was the femoral artery with a 20mm diameter.It was reported that the coil was grabbed and removed from the patient.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician repositioned the coil 2 times.The physician did not attempt to detach the coil or rotate the delivery pusher during the procedure.Continuous flush was administered during the procedure.The echelon catheter was also separated/broke in the distal section during use.There was no friction or difficulty during the injection and there was no force applied during delivery or removal.The catheter was not entrapped/stuck.There was vasospasm.The catheter was not stuck inside the guide catheter.There was no surgical or medicinal intervention required.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
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
H3: product analysis of qc-2-2-helix, lot# 228268873 as found condition: the axium device and echelon-10 micro catheter were returned for analysis within a shipping box and within individual unsealed plastic biohazard pouches.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.No detachment attempts using an instant detacher was observed at this location.The break indicator was found kinked and broken with the release wire retracted, indicative of a manual detachment.No damages or irregularities were found with the remaining pusher.The coin was found retracted out of the lumen stop.The coin was found undamaged.The shield coil was found damaged.The implant coil was already detached and found damaged.No damages or irregularities were found with the echelon-10 hub, micro catheter body, distal tip or marker bands.The distal tip was found shaped.No breaks were found along the length of the micro catheter.Solidified onyx was found within the hub and throughout the micro catheter body.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" could not be confirmed.Although the implant was returned detached, the pusher was found broken at the break indicator and the release wire was retracted, detaching the implant as expected by the detachment subassemblies.The customer report of ¿catheter separation/break¿ also could not be confirmed.The micro catheter was found unbroken.Dried onyx was found within the echelon-10 micro catheter, which is not labeled for use the echelon-10.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; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21718374
• Report Number: 9617601-2025-00304
• Device Sequence Number: 11714466
• Product Code: KRD
• UDI-Device Identifier: 00847536037267
• UDI-Public: 00847536037267
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K233420
• 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): 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-2-2-HELIX
• Device Catalogue Number: QC-2-2-HELIX
• Device Lot Number: 228268873
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 05/09/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/24/2025; 06/03/2025
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 83 KG