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

Model Number	105-7100-060
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Ischemia (1942); Obstruction/Occlusion (2422); Ischemia Stroke (4418); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of h3: device received, analysis not yet completed.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 the patient was undergoing treatment for an ischemic stroke, middle meningeal artery (mma) embolization.It was noted that the patient's vessel tortuosity was normal.The angiographic result post-procedure was left m4 occlusion.It was reported that when drawing up dmso into the syringe provided in the onyx kit, the luer-locked syringe was attached to the duo 167 microcatheter, infused dmso as usual.Upon removing the dmso syringe, the inner tip of the syringe broke off and remained in the microcatheter hub.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information was received.Medwatch report (mw5178827) provided clarification of event details.It was reported that the onyx 18 kit dsmo syringe was attached to a non-medtronic microcatheter, dsmo was injected, and the dsmo syringe was removed.The onyx syringe was attached to the microcatheter and resistance was met during an attempt to inject onyx 18 liquid embolic.The dsmo syringe was inspected and found that the tip of the syringe was missing and had remained in the microcatheter.The microcatheter was removed and replaced with a new one.A new onyx kit was opened, mixed per the instructions for use (ifu) and administered to complete the procedure.The patient was undergoing liquid embolization of the left middle meningeal artery (mma).During post mma embolization intra procedure scanning, it was confirmed that left m4 occlusion with small left frontal lobe parenchymal phase decrease was identified.Post procedure mri confirmed left (distal) m4 occlusion with left frontal lobe infarct.Ancillary devices included headway duo microcatheter 167 cm.
Additional Manufacturer Narrative
Product analysis as found condition: the dmso syringe was returned for analysis within a shipping box and within a resealable plastic biohazard pouch.The duo 167 micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: the dmso syringe was found with the tip broken.The tip break location was found at the base of the tip.Testing/analysis: n/a conclusion: based on the customer report and device analysis, the customer report of ¿syringe damage¿ was confirmed, however, the cause could not be determined.It is possible that the customer incorrectly connected the dmso syringe to the hub (at an angle), or excessive force was used, causing the tip to break from the syringe and remained within the micro catheter.There is also an indication that the event could be related to a potential manufacturing issue, therefore a device history record is reviewed.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: ONYX AVM
• 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: 23770541
• Report Number: 2029214-2025-02598
• Device Sequence Number: 21268027
• Product Code: MFE
• UDI-Device Identifier: 00847536006171
• UDI-Public: (01)00847536006171(17)280107(10)D063903
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 105-7100-060
• Device Catalogue Number: 105-7100-060
• Device Lot Number: D063903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 90 KG