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

Model Number	FC-3-8-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a coil was stuck in the distal section of the catheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the spring coil could not be pushed out of the catheter smoothly, but was successfully implanted after replacement.The catheter and coil were not damaged.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information was received stating that the cause of the resistance was not determined.The coil came out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.The catheter was a medtronic product.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the axium prime coil was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within an opened axium prime coil inner pouch.The unknown micro catheter used in the event was not returned.Visual inspection/damage location details: the axium prime coil pushwire was found to be kinked within introducer sheath at ~75.9cm from proximal end.The implant coil was found to be already detached and not returned.The axium prime could not be pushed out further from the introducer sheath for further evaluation as it was found to be stuck.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime could not be used for resistance testing with an in-house micro catheter due to its 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 FRAMING COIL
• 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: 22127822
• Report Number: 2029214-2025-01286
• Device Sequence Number: 12932464
• Product Code: KRD
• UDI-Device Identifier: 00847536038622
• UDI-Public: 00847536038622
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162704
• 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
• Report Date (Section B): 06/02/2025

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: 03/24/2026
• Device Model Number: FC-3-8-3D
• Device Catalogue Number: FC-3-8-3D
• Device Lot Number: 226235050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 03/24/2023
• 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