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

Model Number	APB-3-4-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
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.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 treatment of an anterior communicating artery aneurysm using the axium prime bare hx coil, the coil became stuck at the front end of the protective sheath and could not be retrieved into the sheath.The procedure involved the insertion of an echelon 10 microcatheter to the lesion site, where the first coil was successfully placed.However, during the hydration of the second coil, it became stuck.The surgeon suspected a quality issue with the coil and replaced it.After hydration, the filling was completed with two additional coils, and angiography confirmed dense filling.The coil and microcatheter were then removed, and the surgery was completed.No patient complications have been reported as a result of this event.The aneurysm max diameter was 4mm, and the neck diameter was 2mm.The patient's blood flow and vessel tortuosity were normal.
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 that a continuous saline flush was administered and maintained as indicated in the ifu.The cause of the resistance was not determined.
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; within a dispenser coil and within an introducer sheath.Visual inspection/damage location details: the introducer sheath was found correctly assembled on the axium prime device with the wavelock on the proximal end.No damages or irregularities were found with the axium prime pusher.The distal axium prime implant coil was found already deployed out of the distal introducer sheath.The implant coil was found stretched/damaged and knotted.Testing/analysis: the implant coil could not be retracted back within the introducer sheath due to the knot found.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿resistance/failure to resheath¿ was confirmed.The cause of the failure was due to the knotting found with the implant.It is possible that the knot occurred during the hydration step as the introducer sheath would have not allowed the implant to knot when it is within the sheath.It is possible the device was not held vertically during retrieval back within the sheath, causing the implant to knot.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: 21079724
• Report Number: 9617601-2025-00030
• Device Sequence Number: 12886152
• Product Code: KRD
• UDI-Device Identifier: 00763000313951
• UDI-Public: 00763000313951
• 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,Followup,Followup
• Report Date (Section B): 04/08/2025

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-3-4-HX-ES
• Device Catalogue Number: APB-3-4-HX-ES
• Device Lot Number: 229795533
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 01/08/2025; 03/14/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/30/2025; 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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 Age: 68 YR
• Patient Sex: Female