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

Model Number	105-5096-000
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was diagnosed with an intracranial arteriovenous malformation (avm).The surgeon used a.010 micro guidewire to super-select the distal malformed vessels, successfully advancing the guidewire distally.However, the apollo microcatheter could not track and be pushed to go upper despite multiple attempts.The surgeon indicated that there might be an issue with the inner diameter of the microcatheter.After replacing to a marathon microcatheter, the procedure was successfully completed.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.There was resistance in the distal section of the catheter.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 femoral artery with a diameter of 10 mm.The patient is alive with no injury.Additional information received clarified that the microguidewire could not come out, and the surgeon considered whether the microcatheter's inner diameter was too small to come out.Additional information was received stating that a stryker 0.010 micro guidewire, lot unknown was used in this event.
Additional Manufacturer Narrative
H3: product analysis: as found condition: the apollo catheter was returned within a shipping box, a plastic bio-pouch, and an open apollo inner pouch.Visual inspection/damage location details: no damage was found with the apollo catheter hub.No bends or kinks were found with the catheter body.The catheter distal tip was found detached from the catheter.The detached tip was not returned.Testing/analysis: the apollo catheter was flushed, water exited from the distal end.An in-house tapered mandrel was inserted through the apollo catheter without issue.The apollo catheter ldpe overlap was measured to be 1.3 mm, which is within specification.Conclusion: based on the device analysis and reported information, the customer's "catheter resistance" and ¿catheter kink/damage¿ reports could not be confirmed.No issues were encountered during testing.In addition, no damage was found with the apollo catheter that would have contributed to the reported event.Possible causes of ¿catheter resistance¿ include incompatible devices, patient vessel tortuosity, guidewire damage, insufficient catheter flushing, or insufficient guidewire preparation.The guidewire used in the event was not returned and the make/model was not provided.Therefore, any contributing factors from the guidewire could not be assessed.The guidewire was prepared, and the catheter was flushed as indicated in the ifu, ruling out insufficient catheter flushing and insufficient guidewire preparation.In this event, it is possible that the patient¿s ¿moderate¿ vessel tortuosity contributed to the reported event; however, the cause could not be determined.Regarding the detachment of the apollo distal tip, as this was not reported by the customer, it is possible that the distal tip detached upon return to medtronic.However, the cause could not be determined.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 ; 7635265677
• MDR Report Key: 23397326
• Report Number: 2029214-2025-02286
• Device Sequence Number: 13256662
• Product Code: MFE
• UDI-Device Identifier: 00763000446758
• UDI-Public: (01)00763000446758(17)270204(10)B700677
• 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
• Report Date (Section B): 10/27/2025

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: B700677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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: 63 YR
• Patient Sex: Male