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

Model Number	105-5096-000
Medical Device Problem Codes	Burst Container or Vessel (1074); Compatibility Problem (2960); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an apollo catheter occluded and ruptured (intact) during onyx 34 injection.The patient was undergoing onyx liquid embolization surgery.It was noted the patient's vessel tortuosity was moderate.Mma  access vessel diameter was 1.5 mm.No patient symptoms or complications were associated with this event.Slight onyx embolus visible in proximal mma, was not blocking flow appeared to be no effects on patient.Physician felt resistance pushing onyx and catheter slightly buckled, all of a sudden noticed dark spot on fluoro about 30-40cm proximal to catheter tip in proximal mma.Pulled catheter out and catheter was clearly ruptured mid-catheter at a proximal portion of orange segment.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).The catheter was inspected or tested prior to use.The catheter occlusion occurred during onyx injection.There was friction or difficulty during delivery.The injection rate was unknown at the time of reporting; typical injection rate lower than 0.3ml/min.
Additional Manufacturer Narrative
Continuation of d10: onyx 34 liquid embolic product id 105-7100-080 (lot unknown);  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: 50898067
• Report Number: 2029214-2026-01915
• Device Sequence Number: 21503822
• Product Code: MFE
• UDI-Device Identifier: 00763000446758
• UDI-Public: (01)00763000446758(17)281210(10)D092570
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 105-5096-000
• Device Catalogue Number: 105-5096-000
• Device Lot Number: D092570
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 02/05/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Male