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

Model Number	QC-1.5-2-HELIX
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition: three coil devices were returned for analysis within a shipping box; within an opened axium outer carton; within an opened axium inner pouch and within individual introducer sheaths.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the pusher.The implant coil was found stretched and damaged within the introducer sheath with the polypropylene filament broken.The introducer sheath was found damaged at ~13.0cm from the distal end.Testing/analysis: the implant coil could not be advanced out of the introducer sheath as it was found stuck.The coil device could not be used for resistance testing with an in-house micro catheter due to the damaged condition.Corrected product analyssi summery included.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 use of a bare axium helix coil, there were issues with coil resistance and the coil becoming stuck in the catheter, specifically at the catheter hub.The coil was also reported to be damaged.The device and any accessory devices were prepared as indicated in the instructions for use.The coil could not be pushed into the catheter.The customer was notified that the product should be returned.There was no patient involved.
Additional Manufacturer Narrative
Product analysis: as found condition: three coil devices were returned for analysis within a shipping box; within an opened axium outer carton; within an opened axium inner pouch and within individual introducer sheaths.The unknown micro catheter used in the event was not returned for analysis.It is not possible to determine which device belongs to which pli and therefore will be analyzed together.Visual inspection/damage location details: (first coil) no damages or irregularities were found with the pusher.The implant coil was found stretched and damaged within the introducer sheath with the polypropylene filament broken.The introducer sheath was found damaged at ~13.0cm from the distal end.(second coil) no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the pusher or implant coil.(third coil) no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the pusher.The implant coil was found damaged within the introducer sheath.Testing/analysis: (first coil) the implant coil could not be advanced out of the introducer sheath as it was found stuck.The coil device could not be used for resistance testing with an in-house micro catheter due to the damaged condition.(second coil) the implant coil was advanced out of the introducer sheath with no resistance encountered.An in-house echelon-10 micro catheter was then used for resistance testing.The returned coil was inserted into the echelon-10 hub, through the micro catheter body and out the distal end with no resistance encountered.(third coil) the implant coil was advanced out of the introducer sheath against high resistance.The coil device could not be used for resistance testing with an in-house micro catheter due to the damaged condition.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 HELIX
• 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: 21684421
• Report Number: 2029214-2025-00759
• Device Sequence Number: 9419581
• Product Code: KRD
• UDI-Device Identifier: 00847536037229
• UDI-Public: 00847536037229
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 11/16/2025
• Device Model Number: QC-1.5-2-HELIX
• Device Catalogue Number: QC-1.5-2-HELIX
• Device Lot Number: 225508115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 03/25/2025
• Date Device Manufactured: 11/16/2022
• 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