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

Model Number	QC-10-30-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
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 there were no issues that resulted in the coil stretch to the apb-1-2-3d-es.Regarding the coil qc-10-30-3d, no instat detacher was used.No less than 3manual attempts to detach.
Additional Manufacturer Narrative
Product analysis: as found condition- the axium device was returned for analysis within a shipping box and within a sealed, labeled, plastic biohazard pouch.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found to be securely attached to the coupler tube.There was no evidence of detachment attempts using an instant detacher at this location.The break indicator was found intact.There were no evidence of manual detachment attempts at this location.The pusher was found kinked at ~155.4cm from the proximal end.The coin was found present and still against the lumen stop.No damages or irregularities were found with the shield coil.The implant coil was found still attached to the pusher.The implant coil was found to be slightly stretched and damaged with the polypropylene filament intact.Testing/analysis - a detachment was attempted by breaking the pusher at the break indicator and retracting the release wire, successfully detaching the implant coil with no issues.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
Continuation of d10: product id apb-1-2-3d-es (lot: 229175911); product type: ; implant date n/a; explant date n/a.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 information regarding issues with two different axium coils which occurred during the same case.The patient was undergoing a coil embolization procedure to treat an internal carotid artery unruptured saccular aneurysm.The aneurysm max diameter was 15mm and the neck diameter was 7mm.Blood flow and vessel tortuosity were normal.It was reported that the devices were prepared as indicated in the instructions for use (ifu).During the procedure the tail of the apb-1-2-3d-es coil was stretched.The coil was removed and replaced to continue the procedure.During the same case, another axium coil (qc-10-30-3d) could not be detached.The coil was again replaced to complete the procedure successfully.There was no harm or injury to the patient.

• Brand Name: AXIUM 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: 22080224
• Report Number: 9617601-2025-00489
• Device Sequence Number: 8702709
• Product Code: KRD
• UDI-Device Identifier: 00847536037946
• UDI-Public: (01)00847536037946(17)270315(10)228436964
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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: QC-10-30-3D
• Device Catalogue Number: QC-10-30-3D
• Device Lot Number: 228436964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 05/26/2025; 06/28/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/11/2025; 07/23/2025
• Date Device Manufactured: 03/15/2024
• 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 Age: 42 YR
• Patient Sex: Male