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

Model Number	105-5096-000
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
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
Medtronic received a report that during onyx liquid embolic injection, the distal end of the apollo microcatheter ruptured.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an intracranial cerebrovascular malformation.It was noted the patient's vessel tortuosity was normal.Right femoral artery access vessel diameter was 6.0 mm.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).There was no friction or difficulty during delivery.It was unknown if there was any other damage to the catheter.
Additional Manufacturer Narrative
B5 updated 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 after discovering the rupture of the catheter, the surgeon ended the procedure.The cause of the rupture was not determined.The physician did not pause during injection, it was a continuous injection of the liquid embolic agent, and the injection rate was followed as indicated in the ifu.The liquid embolic agent did not get embedded in an unintended location and this event did not require medical intervention.It was reported that everything was normal with patient recovery.
Additional Manufacturer Narrative
H3 product analysis: as found condition: the apollo catheter was returned for analysis within a shipping box and inside of a sealed plastic biohazard pouch.Visual inspection/damage location details: the apollo catheter was found to be occluded with solidified onyx.No damage was able to be confirmed.The catheter body was found to be bent at ~56.9cm and damaged (ruptured) at ~152.7cm from the apollo catheter hub.The detachable tip was found to be detached and not returned.The distal shaft (ldpe) was found to be occluded within solidified onyx.No other anomalies were observed.Testing/analysis: during testing, an attempt to flush the apollo catheter body failed, as no water was able to advanced passed the hub.Next, the distal shaft ldpe overlap was skived opened and measured to be 1.14mm, which was found to be within specification.No further testing was performed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter ruptured with onyx¿ was able to be confirmed, as the returned apollo catheter was returned damaged with a ruptured found at the distal segment of the catheter body.A few possible causes of ¿catheter rupture¿ are but not limited to, slow injection rate, and/or pauses longer than 2 minutes, injection against resistance (premature solidification): causes over-pressurization, and/or injection rate too high; however, the root cause for the rupture was unable to be determined.Regarding the catheter occlusion, a few possible causes for the occlusion to occur are but not limited to, onyx solidification (i.E.Exposure to water, saline, blood, contrast solution), and/or catheter damage (i.E.Kinks, bends).No cause was able to be determined.It was noted that the patient's vessel tortuosity was normal.The report mentions that no friction or difficulty occurred during delivery.In addition, during injection,¿it¿was a continuous injection of the liquid embolic agent, and the injection rate was followed as indicated in the ifu.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: 24248095
• Report Number: 2029214-2026-00217
• Device Sequence Number: 9970288
• Product Code: MFE
• UDI-Device Identifier: 00763000446758
• UDI-Public: (01)00763000446758(17)270904(10)B790011
• 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): 04/21/2026

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: B790011
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/06/2026; 03/27/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/04/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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: 9 YR
• Patient Sex: Male