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

Model Number	QC-1.5-4-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
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 the treatment of an unruptured aneurysm in the left ophthalmic artery using an axium coil, the device could not be detached during the push process.The aneurysm had an amorphous morphology with a maximum diameter of 4.5 mm and a neck diameter of 3.3 mm.The procedure involved a sheath, microcatheter, and guidewire, all prepared as indicated in the instructions for use.The physician attempted to detach the coil with the instant detacher once, and then manually via hypotube five times, but the coil remained non-detached.The microcatheter and instant detacher were discarded after use, and the product was replaced by another manufacturer's product.The patient's blood flow was normal, and vessel tortuosity was moderate.The patient outcome was reported as alive with no injury.No patient complications have been reported as a result of 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.
Event or Problem Description
Additional information received that the actions/interventions taken to resolve the failure to detach were repeatedly using the backup detachment, found that it could not be detached.The cause of the failure to detach was not determined.Prior to coil non-detachment, there were no issues encountered.There was no pushwire damage observed after removal from the patient.
Additional Manufacturer Narrative
H3: the axium device was returned.The actuator interface was found loose within the coupler tube, indicative of detachment using an instant detacher.The break indicator was found unbroken.No evidence of manual detachment attempts was found at this location.The axium pusher was found kinked at ~ 80.5cm and bent at ~160.0cm from the proximal end.The distal ~3.0cm of the pusher was found bent/curled into a helix shape.The coin was found partially retracted out of the lumen stop.The release wire/coin was found damaged.The implant coil was still attached to the pusher and found damaged.The implant became detached during analysis due to light handling.The lumen stop was found damaged (ovalized).The loose actuator interface was pulled, and the coin/release wire did not freely move as it was found stuck.The inner diameter of the lumen stop could not be measured due to the damages.The coin was measured to be ~0.077mm @ 0.063mm, ~0.89mm @ 0.127mm, and ~0.090mm @ 0.275mm, which is within specification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.105mm @ 0.127mm; and 0.086mm ¿ 0.108 @ 0.275mm).Based on the customer report and device analysis, the customer report of "non-detachment" was confirmed as the implant was returned still attached to the pusher.The lumen stop and coin/release wire were found damaged, indicative that the coin was jammed within the inner diameter of the lumen stop, likely leading to the reported non-detachment.The cause of the coin stuck within lumen stop could not be determined.The distal pusher was found curled into a helix shape, indicative the release wire retracting while stuck within the pusher, causing the pusher to bend into itself.In addition, the release wire did not move smoothly within the pusher, potentially contributing towards difficulty detaching the implant.Customer reported multiple manual detachment attempts, however, the pusher was unbroken.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: 21066166
• Report Number: 9617601-2025-00014
• Device Sequence Number: 16998536
• Product Code: KRD
• UDI-Device Identifier: 00847536037243
• UDI-Public: 00847536037243
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/10/2025

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: 03/25/2026
• Device Model Number: QC-1.5-4-HELIX
• Device Catalogue Number: QC-1.5-4-HELIX
• Device Lot Number: 226234961
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 02/13/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/31/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male