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

Model Number	105-5096-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Paralysis (1997); Foreign Body In Patient (2687); Intracranial Pressure Increased (4586)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that during the embolization of a vascular malformation, the microcatheter became adherent to the vessel.Detachment was performed, but the microcatheter broke in the middle at a non-designated detachment point, leaving the proximal broken end in the left internal carotid artery and middle cerebral artery.Blood flow was not affected.It was recommended to first surgically treat the intracranial vascular malformation and aneurysm, and, depending on the situation during the procedure, to remove the retained microcatheter in the internal carotid artery if possible.The patient was discharged on their own and transferred to the department of neurosurgery at (b)(6) affiliated hospital for further treatment.The cause of the event was unable to be determined.It was considered that the connection between the soft segment of the microcatheter and the external support segment was not secure.
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.
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
Additional information received reported that the patient was being treated for a left frontal lobe malformation, cerebral hemorrhage, 2cm in size.There was moderate to severe vessel tortuosity.The patient had a brain herniation and right-sided hemiplegia.The tip portion (25cm) remained inside the skull, while the rest was removed.The aneurysm was not treated.No further interventions or treatment were performed.The customer indicated that the dsa equipment imaging was normal.

• 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: 23705238
• Report Number: 2029214-2025-02532
• Device Sequence Number: 18808969
• Product Code: MFE
• UDI-Device Identifier: 00763000446758
• UDI-Public: (01)00763000446758(17)280123(10)D017353
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: D017353
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 02/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male