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

Model Number	105-5096-000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Medtronic received a report of premature detachment of an apollo catheter tip.The patient was undergoing surgery for treatment of an arteriovenous malformation (avm).It was noted the patient's vessel tortuosity was moderate.The access vessel was the radial artery with a 3 mm vessel diameter.It was reported that during removal of the microcatheter, the operator noted that the distal tip of the microcatheter detached spontaneously.It was noted that there was tip premature detachment.No friction or difficulty was observed during injection.There was no force applied during removal.The catheter tip was not entrapped or stuck.There was no vasospasm.There was no surgical or medicinal intervention required.It was not specified if this occurred during onyx injection.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The catheter was flushed as indicated in the ifu.
Additional Manufacturer Narrative
B5 updated h3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6 updated 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
Additional information received reported that no causes or contributing factors for the premature detachment were identified or available.It remains unknown if the detachment occurred during onyx injection.There was no resistance when the apollo was being advanced or retrieved.It is unknown what the anatomical location of the apollo tip was.The subject is recovering normally from the procedure and there are no adverse events to report.The anatomy tortuosity was severe.It was unknown if there was any note of vessel calcification.The guide catheter and guidewire were non-medtronic products.The guidewire was hydrated as indicated in the ifu.There was no kink or damage noticed on any of the devices.During the device use/ procedure, continuous flush was maintained through the guide catheter.The procedure was completed by replacing the microcatheter with a new one.

• 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 ; 7635265677
• MDR Report Key: 24632203
• Report Number: 2029214-2026-00456
• Device Sequence Number: 18432876
• Product Code: MFE
• UDI-Device Identifier: 00763000446758
• UDI-Public: (01)00763000446758(17)280325(10)D033408
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2026

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: 105-5096-000
• Device Catalogue Number: 105-5096-000
• Device Lot Number: D033408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 05/05/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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: 65 YR
• Patient Sex: Male