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

Model Number	105-5096-000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the apollo catheter was damaged during hydration.It was reported that during the procedure, the assistant took out the apollo catheter from the packaging as usual and performed routine hydration.During hydration, it was found that there was no detachment zone at the tip end, which led to a complaint being raised.The device was then replaced with another apollo, which did not exhibit any abnormalities.The procedure was completed successfully, and the patient experienced no adverse reactions postoperatively.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed per the ifu.No patient symptoms or complications were associated with this event.
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 dispenser coil.Damage location details.No damages were found with the apollo catheter hub.No bends or kinks were found with the apollo catheter body.The apollo catheter detachable tip was found to be detached and not returned.No damages were found with the apollo catheter distal tip.Testing/analysis.The apollo catheter was flushed; water exited from the distal tip.Conclusion.Based on the device analysis and reported information, the customer's report of "catheter kink/damage" report could not be confirmed.No defect was found with the returned apollo catheter that would have contributed to the reported event.The event description also mentions that the apollo catheter also had ¿tip premature detachment¿.The tip detachment was able to be confirmed, as the returned apollo was missing the detachable tip upon inspection.The report mentions that ¿during hydration, it was found that there was no detachment zone at the tip end¿.Unintended detachment can occur if the ldpe overlap is too short, if the distal end of the catheter is not handled with care, or if it is removed from within the dispenser coil with difficulty.However, the cause of the tip detachment could not be determined.The detachable tip was not returned for assessment.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed per the 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.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: 23782834
• Report Number: 2029214-2025-02608
• Device Sequence Number: 21368368
• Product Code: MFE
• UDI-Device Identifier: 00763000446758
• UDI-Public: (01)00763000446758(17)270325(10)B719128
• 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): 12/11/2025

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: B719128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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: Unknown