MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number	105-5091-150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an axium coil encountered difficult placement.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for a ruptured right mca bifurcation aneurysm with a saccular morphology.Aneurysm dimensions: max diameter 4.3 mm and neck diameter 2.4 mm.The patient¿s blood flow was normal and vessel tortuosity was severe.Physician decided to treat a ruptured wide neck right mca bifurcation aneurysm with balloon assisted coiling.Considering the measurements of aneurysm, he decided to take this as 1st coil.But he was unable to deploy this coil due to morphology of the aneurysm even with balloon inflation also.This coil was not fitting inside the aneurysm at all due to 15cm length, so he took out this coil <(>&<)> deployed fc-4-10-3d as 1st coil which framed nicely.The coil was not implanted at the intended location.There were no additional steps/surgical interventions required to remove or secure the coil.The device did not jump during deployment.The vessel was not damaged.The tip of the catheter was not under stress.The tip of the catheter moved during deployment.The physician did not rotate the delivery pusher during procedure.The aneurysm did not rupture.There were no patient symptoms or complications associated with this event.Additional information was received that an echelon catheter was used.The cause of the axium difficult placement was due to morphology, wide neck aneurysm and length of the aneurysm, and this axium couldn¿t be placed.
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
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 stating that the cause of the catheter tip moving during deployment was not determined.

• Brand Name: ECHELON
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 22077247
• Report Number: 2029214-2025-01237
• Device Sequence Number: 13148516
• Product Code: KRA
• UDI-Device Identifier: 00847536005969
• UDI-Public: 00847536005969
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093750
• 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): 06/03/2025

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: 09/17/2026
• Device Model Number: 105-5091-150
• Device Catalogue Number: 105-5091-150
• Device Lot Number: B789111
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 05/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/03/2025
• Date Device Manufactured: 09/17/2024
• 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 Age: 62 YR
• Patient Sex: Male