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

Model Number	QC-2-4-3D
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
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
It was reported that during the treatment of a ruptured saccular aneurysm in the internal carotid artery, a coil-related issue occurred with the axium helix coil and axium 3d coil, where the coil became stuck in the sheath three times.The aneurysm had a maximum diameter of 5 millimeters and a neck diameter of 2 millimeters, with moderate vessel tortuosity and normal blood flow.The devices were prepared as indicated in the instructions for use.The issue involved coil resistance and the coil being stuck in the sheath.The resolution or outcome of the event was not specified.Additional information received reported the coil accidentally broke during the procedure, and no detachment attempts had been made.There was no kink/damage observed on the pushwire.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: vis (m-78210), 203cm ruler (m-83361), pin gauge sets (m-84082, m-84080).As found condition (condition of returned device): 3 axium implant coils were returned for analysis within a shipping box; within their opened axium implant coil outer cartons and within their opened axium implant coil inner pouches.Visual inspection/damage location details: the axium implant coil was returned within introducer sheath.The axium implant coil pushwire was broken but retained by release wire at break indicator.The axium implant coil was found to be stretched and damaged within introducer sheath.The axium implant coil was unable to be pushed out from introducer sheath for further analysis as it was found to be stuck.No other anomalies were observed.Testing/analysis (including sem reports): the axium implant coil tip od (outer diameter) was measured to be 0.0113¿ which is within specifications.The id (inner diameter) of the introducer sheath was measured to be 0.0180¿ which is within specifications.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed; however, the root cause was unable to be determined.The customer reported preparing the axium implant coil as indicated in the ifu prior to use.It is possible insufficient preparation of the axium implant coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.Based on the analysis performed, the customers report of ¿coil separation/break¿ was unable to be confirmed as the pushwires were returned with the implant coil still attached.H6.Coding updated based on analysis findings.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
Correction: information in previously submitted report contained incorrect device evaluation in formation in section h11 regarding h3.The correct information in reported below.H3.Product analysis: equipment used: vis (m-78210), 203cm ruler (m-83361), pin gauge sets (m-84082, m-84080) as found condition (condition of returned device): 3 axium implant coils were returned for analysis within a shipping box; within their opened axium implant coil outer cartons and within their opened axium implant coil inner pouches.Visual inspection/damage location details: the axium implant coil was returned within introducer sheath.No bends or kinks were found with the axium implant coil pushwire.The axium implant coil was found to be stretched and damaged within introducer sheath.The axium implant coil was unable to be pushed out from introducer sheath for further analysis as it was found to be stuck.No other anomalies were observed.Testing/analysis (including sem reports): the axium implant coil tip od (outer diameter) was measured to be 0.0113¿ which is within specifications.The id (inner diameter) of the introducer sheath was measured to be 0.0190¿ which is within specifications.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed; however, the root cause was unable to be determined.The customer reported preparing the axium implant coil as indicated in the ifu prior to use.It is possible insufficient preparation of the axium implant coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.Based on the analysis performed, the customers report of ¿coil separation/break¿ was unable to be confirmed as the pushwires were returned with the implant coil still attached.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 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: 21063999
• Report Number: 9617601-2025-00010
• Device Sequence Number: 19685397
• Product Code: KRD
• UDI-Device Identifier: 00847536037625
• UDI-Public: 00847536037625
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2025

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 Expiration Date: 10/07/2025
• Device Model Number: QC-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: 225189047
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 02/06/2025; 02/06/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/03/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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