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

Model Number	105-5095-000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during the embolization procedure for an external carotid artery avm, after the 8f guiding catheter reached the opening of the external carotid artery, the chikai10 guidewire was used to guide it into the apollo microcatheter (model: 105-5095-000, lot: b798476).Both the microcatheter and guidewire were thoroughly hydrated, and the process was smooth.The microcatheter was advanced via the external carotid artery approach into the malformation nidus.After flushing the microcatheter lumen with normal saline, dmso was injected, followed by onyx glue (model: 105-7000-060, lot: b809303).The injection was performed at a steady rate, and no resistance or catheter blockage was observed.The onyx glue dispersed well.However, during continued injection, onyx glue was found to be leaking from a point approximately 5 cm proximal to the detachment site.The operation was then stopped and the microcatheter was removed.Catheter leak was in the middle section.The catheter was inspected or tested prior to use.The leak was observed during use.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for external carotid artery arteriovenous malformation (avm) embolization.It was noted the patient's vessel tortuosity was moderate.Access vessel was the right femoral artery with a 7mm diameter.
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 due to the apollo leak, onyx was injected unintentionally in the pretemporal region.As previously noted, the patient had not associated symptoms or other complications.The cause of the catheter leak was not determined.The catheter was removed and the surgery was ended.
Additional Manufacturer Narrative
B5 updated with additional information received.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
Product analysis as found condition: the apollo catheter was returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, and within a plastic glove.Visual inspection/damage location details: no flash or molded voids were observed in the hub; however, the catheter hub was found to be occluded with solidified liquid onyx.The catheter body was found in good condition.The detachable tip was found to be detached and not returned.No other anomalies were observed.Testing/analysis: the total and usable length of the apollo catheter were both unable to be accurately measured, as the detachable tip was not returned for assessment.During testing, the apollo catheter failed to be flushed with water.No further testing was able to be performed.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿catheter leak¿ was unable to be confirmed; however, the event could not be ruled out.The apollo catheter was returned with the catheter hub occluded with solidified onyx and the detachable tip missing (not returned).A possible cause for a catheter leak is but not limited to catheter rupture/damage/puncture/breaks or separations; however, the root cause was unable to be determined.During testing, the catheter failed to be flushed; therefore, no leak was able to be reproduced.No damage was found on the catheter body that would lead to a possible leak.During testing, the apollo failed to be flushed; therefore, no possible cause was able to be determined.The guidewire used in the procedure and the detachable tip were both not returned; therefore, any contribution the guidewire and/or the detachable tip had towards the catheter leak was unable to be assessed.The chikai10 guidewire was found to be compatible with the apollo microcatheter.It was noted that the patient's vessel tortuosity was moderate.The reported device and any accessory devices were prepared, and the catheter was flushed as indicated in the instructions for use (ifu).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: 23511449
• Report Number: 2029214-2025-02366
• Device Sequence Number: 15879249
• Product Code: MFE
• UDI-Device Identifier: 00763000446741
• UDI-Public: (01)00763000446741(17)270813(10)B798476
• 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): 01/27/2026

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: B798476
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 01/13/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 87 KG