MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-14-40-3D
Medical Device Problem Codes	Stretched (1601); Packaging Problem (3007)
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
H3: the axium pusher was returned for analysis.The dispenser coil and introducer sheath were also returned.The axium pusher was found broken between the positive load indicator and break indicator.The release wire was fully retracted out of the distal pusher segment.No other damages or irregularities were found with the axium pusher.The shield coil was found broken and the implant coil was already detached and not returned for analysis.Based on the device analysis and reported information, the customer¿s report of ¿prod damaged/deformed out of pkg¿ could not be confirmed but could not be ruled out.The pusher was broken, and the release wire was retracted, detaching the device as intended by the detachment subassemblies.The shield coil was found broken, indicative of resistance.It is possible the damage occurred during production, during transportation, or upon opening the package and attempting to remove the product or after removing it from the package.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 information regarding an axium coil that was stretched prior to use in the patient's body.The patient was undergoing a coil embolization procedure to treat c4 segment giant lateral unruptured saccular aneurysm.The aneurysm max diameter was 13mm and the neck diameter was 9mm.Patient's vessel tortuosity was normal.It was reported that during the initial unpacking of a the axium coil, it was found stretched at the coil body and connecting rod outside the patient's body.It was noted that the coil and all accessory devices were prepared according to the instructions for use (ifu).The stretched coil was replaced with another model, and the surgery proceeded successfully.As the issue was observed during unpacking and outside the patient's body, it is considered that there is no patient involvement.Additional information received reported there was no damage or evidence of tampering to device packaging.The proximal end of the pushwire was secured in the guidewire clip (black rubber stopper) when the package was opened.The cause of the damage was unknown.No prep was performed prior to the damage being seen.

• Brand Name: AXIUM 3D
• 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: 21749128
• Report Number: 9617601-2025-00317
• Device Sequence Number: 18514534
• Product Code: KRD
• UDI-Device Identifier: 00847536037984
• UDI-Public: 00847536037984
• 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
• Report Date (Section B): 04/01/2025

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-14-40-3D
• Device Catalogue Number: QC-14-40-3D
• Device Lot Number: 229115295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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