MAUDE Adverse Event Report: Micro Therapeutics, Inc. dba ev3 APOLLO; AGENT, INJECTABLE, EMBOLIC

Model Number	105-5096-000
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Codes	Paralysis (1997); Facial Paralysis (4585)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that onyx was being used for embolization of an arteriovenous fistula (av fistula).An apollo 3 cm tip microcatheter was used to deliver the onyx.The apollo was advanced through the middle meningeal artery (mma) feeder, and the onyx was flowing as intended with minimal reflux.At one point, the onyx was still flowing, but it was no longer visible on the roadmap image, which had been magnified on the fistula.The physician did not feel any pressure during injection and stopped when the flow could no longer be seen.After zooming out, the physician observed that the onyx was also flowing proximally due to a hole in the apollo microcatheter.This caused onyx to flow into the petrosal branch and resulted in facial paralysis in the patient.The reported issue was a catheter leak, located distally, which was observed during use despite the catheter having been inspected and tested prior t o use.It was noted the patient's vessel tortuosity was normal.Access vessel was the mma.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).Ancillary devices include a guide catheter, apollo microcatheter, balt 12/14 hybrid guidewire, onyx 18 and 34 liquid embolic.
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: APOLLO
• 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 ; +1(763)526-5677
• MDR Report Key: 50899068
• Report Number: 2029214-2026-01920
• Device Sequence Number: 13451513
• Product Code: MFE
• UDI-Device Identifier: 00763000446758
• UDI-Public: (01)00763000446758(17)290309(10)D102472
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/25/2026

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: 105-5096-000
• Device Catalogue Number: 105-5096-000
• Device Lot Number: D102472
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 03/24/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Male