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

Model Number	APB-1-2-3D-ES
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a procedure involving the axium prime bare 3d 1mm x 2cm extra soft coil, the physician encountered resistance as the coil became stuck in the catheter.The coil subsequently teared off when the physician attempted to push it through the catheter/balloon.The patient's blood flow and vessel tortuosity were reported as normal, and there were no patient symptoms or complications associated with this event.The catheter was not damaged, and the coil was not damaged.The product was prepared as indicated in the instructions for use, and the accessory devices were not returned for investigation as they were thrown away.The patient outcome was reported as alive with no injury.No patient complications have been reported as a result of this event.Ancillary devices: other device(s) used eclipse balloon.
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 received reported that the cause of the coil resistance/tear was not determined.The resistance was in the middle of the catheter.The coil did not come out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.No detachment attempts were made, and no kink/damage was observed on the pushwire.
Event or Problem Description
Additional information received reported during preparation, the introducer sheath was not held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
Product analysis: as found condition: the axium prime device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and within an opened axium prime inner pouch.The introducer sheath and eclipse balloon catheter used during the event was not returned for analysis.Visual inspection/damage location details: the distal 2.0cm of the axium prime pusher was found bent/kinked.The implant coil was found separated/broken from the detach element at the coil shell weld with the polypropylene filament broken and not returned for analysis.Testing/analysis: the axium prime device could not be used for resistance testing due to the damaged condition.The axium prime implant coil tip od (outer diameter) could not be measured as it was not returned.The introducer sheath id (inner diameter) could not be measured as it was not returned.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 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: 21918787
• Report Number: 9617601-2025-00427
• Device Sequence Number: 8714942
• Product Code: KRD
• UDI-Device Identifier: 00763000313616
• UDI-Public: (01)00763000313616(17)270717(10)229241584
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup,Followup
• Report Date (Section B): 07/01/2025

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-1-2-3D-ES
• Device Catalogue Number: APB-1-2-3D-ES
• Device Lot Number: 229241584
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 06/27/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/06/2025; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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 Sex: Unknown