MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PGLA 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	PC-16-40-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that axium coil non-detachment occurred.It was noted there was no issue with the instant detacher.It was unknown if the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were reported.
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed valid.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 was received reporting that there were no causes or contributing factors for the non-detachment.There were no issues encountered prior non-detachment.All the information has been confirmed by the physician.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.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: AXIUM PGLA 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 24481876
• Report Number: 2029214-2026-00321
• Device Sequence Number: 9306074
• Product Code: KRD
• UDI-Device Identifier: 00847536044845
• UDI-Public: (01)00847536044845(17)270315(10)B718979
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K233420
• 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): 04/02/2026

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: PC-16-40-3D
• Device Catalogue Number: PC-16-40-3D
• Device Lot Number: B718979
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 04/16/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown