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

Model Number	APB-2-4-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an echelon 10 microcatheter that had resistance.The patient was undergoing a coil embolization procedure to treat a left ophthalmic artery segment unruptured saccular aneurysm.The aneurysm max diameter was 4mm and the neck diameter was 3mm.Blood flow was normal.Vessel tortuosity was moderate.It was reported that the devices were prepared and catheter flushed as indicated in the instructions for use (ifu).There was resistance in the echelon microcatheter during delivery so the devices were removed and replaced to complete the procedure successfully.There was no harm or injury to the patient associated with this event.Additional information was received that clarified that the axium coil had resistance during delivery in the echelon microcatheter.A stryker guidewire also encountered resistance in the catheter.Catheter resistance occurred in the distal section.The coil came out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.There was no kink/damage observed to the catheter or coil after removal.
Additional Manufacturer Narrative
Product analysis: as found condition: the axium prime device and the echelon-10 microcatheter were returned for analysis within a shipping box and wit hin a sealed plastic biohazard pouch.Damage location details: the pushwire was found to be bent at ~7.2cm and at ~135.2cm from the proximal end.The axium prime coil was found to be broken off, with the polypropylene filament broken off the detachable element.The axium prime implant coil was found to be stretched and damaged.No other anomalies were observed.Testing analysis: due to the damaged condition, the axium prime implant coil was unable to be tested in-house.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 PRIME BRPL HLX
• 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: 22475044
• Report Number: 2029214-2025-01562
• Device Sequence Number: 8188226
• Product Code: KRD
• UDI-Device Identifier: 00763000313883
• UDI-Public: (01)00763000313883(17)270801(10)229294003
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• 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
• Report Date (Section B): 07/10/2025

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: APB-2-4-HX-ES
• Device Catalogue Number: APB-2-4-HX-ES
• Device Lot Number: 229294003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 08/01/2024
• 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 Sex: Male