MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX AVM; AGENT, INJECTABLE, EMBOLIC

Model Number	105-7100-060
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a procedure went as planned.However, when the microcatheter was removed at the end of the procedure, the distal end snapped and about 5cm was left behind in the patient.An attempt was made to remove the catheter with a snare, but it was unsuccessful.There was no friction or difficulty during injection.There was no force applied during delivery or removal.The catheter tip was entrapped/stuck.There was no vasospasm.The catheter was not stuck inside the guide catheter.No surgical or medicinal intervention was required.The broken segments remain in the patient in the imax.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for onyx embolization of mma.It was noted the patient's vessel tortuosity was normal.The access vessel was the external carotid artery (eca) - internal maxillary artery (imax) - middle meningeal artery (mma) with a 2.5mm diameter.Ancillary devices include an onyx 18 liquid embolic.Additional information was received that the procedure was completed with an attempt to snare out remaining the microcatheter, but about 15cm was left in patient.It was clarified that the catheter was broken.It was believed that the catheter was entrapped in onyx.The cause of the break and entrapment was not determined.
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.

• Brand Name: ONYX AVM
• Common Device Name: AGENT, INJECTABLE, EMBOLIC
• 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: 21778677
• Report Number: 2029214-2025-00889
• Device Sequence Number: 21040219
• Product Code: MFE
• UDI-Device Identifier: 00847536006171
• UDI-Public: 00847536006171
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030004
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 105-7100-060
• Device Catalogue Number: 105-7100-060
• Device Lot Number: B813025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/04/2025
• Date Device Manufactured: 11/01/2024
• 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 Age: 89 YR
• Patient Sex: Male