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

Model Number	105-5095-000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received reporting that no causes or contributing factors for the event were identified.On the dsa screen, the surgeon observed that a segment of the catheter tip appeared to be detached.There was no resistance when the apollo was being advanced.The detached tip does not remain in the patient and it will not be returned.There has been no adverse events to report.There was no note of vessel calcification.It was asked but unknown what guidewire was used.The guidewire was hydrated as indicated in the ifu.There was no kink or damage noticed on any of the devices.A continuous salineflush was administered and maintained as indicated in the ifu.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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: 50347232
• Report Number: 2029214-2026-01610
• Device Sequence Number: 17648296
• Product Code: MFE
• UDI-Device Identifier: 00763000446741
• UDI-Public: (01)00763000446741(17)271025(10)B813042
• 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
• Report Date (Section B): 09/24/2026

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: 105-5095-000
• Device Catalogue Number: 105-5095-000
• Device Lot Number: B813042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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 Sex: Female