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

Model Number	105-7100-060
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: 105-5095-000 (b690814).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 a treatment for arteriovenous malformation (avm) embolization using an apollo catheter, there was severe vessel tortuosity in the pica with a diameter of 1.5mm.The procedure encountered resistance while passing the microwire, but it eventually reached the desired location.During the injection of onyx, the catheter automatically detached approximately 15cm beyond the detachable tip, resulting in catheter separation due to onyx entrapment and part of the microcatheter remains in the patient.Some part of the micro remained in the artery, and the catheter was broken at the distal end.All broken segments were removed from the patient.The injection was continuous with a waiting time of about 15-20 minutes, and there was no onyx reflux.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No surgical or medicinal intervention was required.No patient complications have been reported as a result of this event.
Event or Problem Description
Additional information received clarified that no parts of the catheter remained in the patient.The cause of the event was not determined.It was reported that there were no issues with the onyx, and it had been implanted in the intended location.
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.

• 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: 20725079
• Report Number: 2029214-2024-02145
• Device Sequence Number: 15070663
• Product Code: MFE
• UDI-Device Identifier: 00836462005044
• UDI-Public: 00836462005044
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 12/02/2024

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: 105-7100-060
• Device Catalogue Number: 105-7100-060
• Device Lot Number: B731734
• 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: 11/17/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 05/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown