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

Model Number	105-7100-060
Medical Device Problem Codes	Entrapment of Device (1212); Migration or Expulsion of Device (1395); Chemical Problem (2893); Unintended Movement (3026)
Health Effect - Clinical Codes	Paresis (1998); Perforation of Vessels (2135); Rupture (2208); Foreign Body In Patient (2687); Movement Disorder (4412); Decreased Level of Consciousness (4591)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
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
It was reported that during the removal of the apollo catheter post embolization of an arteriovenous malformation, there was resistance and tension applied, leading to the rupture of the arteriovenous malformation (avm).The patient experienced motor and sensory loss to the right arm and leg, as detected by neuro monitoring.Vessel perforation occurred, and there was cast separation/movement during catheter removal.Onyx reflux was noted, and the catheter tip was difficult to remove, with the inner lining of the apollo catheter possibly left in the patient.A portion of onyx was displaced upon catheter removal.The devices were prepared according to the instructions for use (ifu).The catheter was flushed as per ifu.Surgery was planned for (b)(6) 2025.Ancillary devices: 5fr 45cm destination sheath, balt hybrid 12-14 guidewire, 038 127cm socrates as intermediate.
Event or Problem Description
Additional information received reported raca not filling, potential ptfe liner still present.Laca collateralizing and patient is moving l upper extremity 3/5, no lower limb movement.There was no resistance upon injection of the liquid embolic agent into the apollo.During injection multiple pauses with total injection time of 9 minutes.The injection rate was followed as indicated in the instructions for use (ifu).Liquid embolic agent got embedded in an unintended location in the ra2.Additional intervention was post the embolization surgical resection of avm.The anatomical location of the apollo tip is the distal a3.
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.
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 the tip and what would seem to be the liner was detached.The inner liner is not referring to the detachable tip.2-4cm of reflux was noted.

• 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: 21649267
• Report Number: 2029214-2025-00714
• Device Sequence Number: 9245832
• Product Code: MFE
• UDI-Device Identifier: 00847536006171
• UDI-Public: 00847536006171
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 105-7100-060
• Device Catalogue Number: 105-7100-060
• Device Lot Number: D008793
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 05/01/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/07/2025; 05/07/2025
• Date Device Manufactured: 01/07/2025
• 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: Life Threatening
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 25 KG