MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-10-30-3D
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted as part of remediation activities associated with capa # 643143, which is addressing mdr reporting guidance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.Product analysis: as found condition: the axium coil was returned within a shipping box; within a sealed plastic bio-pouch; and within an opened axium inner pouch.Visual inspection/damage location details: the axium coil was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.No bent or kink were found with the axium pushwire.No damage was found with the axium implant coil.However, the returned coil was found to be helix coil not 3d coil.No other anomalies were observed.Testing/analysis: the length of coil was measured to be ~12.0cm which is not 30cm.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿incorrect part¿ was confirmed as the length and shape of implant coil does not match with labeling.However, the root cause could not be determined.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.For coil incorrect size see capa572119.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 the coil was pushed out and the diameter of the coil was found to be less than 10mm.The coil was removed and it was found that it was a 2d coil packaged as a 3d coil.A new coil was placed and the issue was resolved.The device was prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 10mm and a 8mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21767143
• Report Number: 2029214-2025-00878
• Device Sequence Number: 15606205
• Product Code: KRD
• UDI-Device Identifier: 00847536030138
• UDI-Public: 00847536030138
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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 Expiration Date: 07/25/2024
• Device Model Number: QC-10-30-3D
• Device Catalogue Number: QC-10-30-3D
• Device Lot Number: B240084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1261-2022
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male