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

Model Number	QC-4-12-3D
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): two axium implant coils were returned for analysis within a shipping box and within a sealed biohazard plastic pouch.The axium implant coils were returned without their introducer sheaths.Visual inspection/damage location details: due to the condition in which the coils were returned; it was unable to be determined which coil belongs to which pli.(coil 1) the axium implant coil pushwire was found to be kinked at ~142.2cm from proximal end.The shield coil was found to be stretched within the implant coil found to be detached and returned.The axium implant coil was found to be stretched and damaged.No other anomalies were observed.(coil 2) the axium implant coil pushwire was found to be kinked at ~51.5cm and at ~150.9cm from proximal end.The axium implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): 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 information that intracranial aneurysm embolization was being performed.After the microcatheter was in place, the detachable coil qc-4-12-3d was selected to form a hoop.The tail ends of two consecutive coils were stretched and replaced it with another new coil, and the operation was successfully completed.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for an unruptured, saccualr aneurysm in the opthalmic artery.The max diameter was 4mm and the neck diameter was 2mm.Patient blood flow was normal and vessel tortousity was minimal.No patient injury or symptoms were reported.Additional information was received stating that there were no issues resulting in the damage that was found.

• 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: 21970047
• Report Number: 2029214-2025-01128
• Device Sequence Number: 8260578
• Product Code: KRD
• UDI-Device Identifier: 00763000320997
• UDI-Public: 00763000320997
• 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: 2025
• Device Explanted Year: 2025
• 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): 05/06/2025

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-4-12-3D
• Device Catalogue Number: QC-4-12-3D
• Device Lot Number: 228012927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/06/2025
• Date Device Manufactured: 01/03/2024
• 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