MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-3-8-3D
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
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 a procedure to treat a ruptured saccular internal carotid artery (ica) aneurysm, an axium coil was stuck in the sheath.It was noted that the devices were prepared as indicated in the instructions for use. the aneurysm had a maximum diameter of 4mm and a neck diameter of 2mm.Vessel tortuosity was moderate and blood flow was normal.The patient experienced no symptoms or complications associated with this event.Ancillary device: echelon microcatheter additional information received reported the coil accidentally broke during the procedure, and no detachment attempts had been made.There was no kink/damage observed on the pushwire.
Additional Manufacturer Narrative
H3: product analysis #(b)(4) :equipment used: video inspection system (m-85519), ruler (m-83360), pin gauge sets (m-84082, m-84081), camera (panasonic lumix dmc-zs5), drawing(s) referenced: d00156061 rev.B; dwgs50796 rev.A as found condition: the axium coil was returned for analysis within a shipping box; within an opened axium outer carton; within an opened axium inner pouch; and within an introducer sheath.Visual inspection/damage location details: the introducer sheath was found assembled inverted on the pusher with the wavelock at the distal end.No damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the axium pusher.The axium implant coil was found slightly damaged within the introducer sheath with a small amount of dried blood found on the implant (figure c).The implant coil was found unbroken.Testing/analysis: the axium implant coil could not be advanced out of the introducer sheath as it was found stuck and was retracted out proximally.The axium implant coil tip od (outer diameter) was measured and found to be 0.0115¿ which is within specification (specification: 0.0108¿ +.0010¿/-.0020¿).The introducer sheath id (inner diameter) was measured and found to be 0.0185¿ (0.4699mm) which is within specification (specification: 0.46mm ± 0.02mm).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.The axium implant coil were found damaged within the introducer sheath.It is possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv/sheath not fully seated within the hub) subsequently causing the implant coil to become stuck.Advancing the coil against resistance would result in damage to the implant.In addition, the introducer sheath was found inverted on the pusher.It is likely that resistance would occur when attempting to push the implant coil out from this portion of the introducer sheath as this portion of the introducer sheath is designed to create resistance with the pushwire portion of the axium coil.It is likely that the customer inadvertently inverted the axium coil following hydration or inspection.A small amount of dried blood was found on the implant, potentially contributing to the resistance.The customer report of ¿coil separation/break¿ could not be confirmed as the implant was found 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 3D
• 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: 21063991
• Report Number: 9617601-2025-00006
• Device Sequence Number: 3302284
• Product Code: KRD
• UDI-Device Identifier: 00847536037700
• UDI-Public: 00847536037700
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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-3-8-3D
• Device Catalogue Number: QC-3-8-3D
• Device Lot Number: 228588510
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2024
• 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 Sex: Unknown