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

Model Number	105-7100-060
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Product Quality Problem (1506); Use of Device Problem (1670); Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that there was an issue with the expiration dates in an onyx kit.The account reported that the onyx kit contained a vial of dmso lot b687507 and onyx 18 lot b035828.The onyx lot b035828 had an expiration date of 2023-06-05, while the dmso and top level assembly had good dating (2027-01-31 and 2026-11-01 respectively).It was noted the top level assembly should have a shorter date than the onyx 18 and dmso, and the account was wondering if the device was packaged this wrong. the event was not associated with a patient.
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
B5 updated with corrected information based on all available information.H6 coding was updated based on all available information.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 there was an issue with the expiration dates in an onyx kit.The account reported that the onyx kit contained a vial of dmso lot b687507 and onyx 18 lot b035828.The onyx lot b035828 had an expiration date of 2023-06-05, while the dmso and top level assembly had good dating (2027-01-31 and 2026-11-01 respectively).It was noted the top level assembly should have a shorter date than the onyx 18 and dmso, and the account was wondering if the device was packaged this wrong.The event was not associated with a patient.Additional information received reported the site lab had discarded the boxes and mixed up all the vials.They took multiple vials out of the box and did not put them back in the correct/corresponding boxes.

• 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: 19795513
• Report Number: 2029214-2024-01279
• Device Sequence Number: 7114225
• Product Code: MFE
• UDI-Device Identifier: 00847536006171
• UDI-Public: (01)00847536006171(17)261101(10)B697287
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: B697287
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 02/26/2024
• 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 Sex: Unknown