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

Model Number	APB-2.5-4-3D-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	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding two axium coils that had resistance in the echelon 10 microcatheter and the catheter was damaged.The patient was undergoing a coil embolization procedure to treat a ruptured saccular aneurysm in the middle cerebral artery (mca).The aneurysm max diameter was 3mm and a neck diameter of 1mm.Patient blood flow was normal and vessel tortuosity was moderate.It was reported that the devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).An axium prime coil could not be advanced through the distal echelon microcatheter.The coil was replaced with another axium coil but the same issue occurred so the system was removed.The catheter was observed to be damaged at the distal end.Neither coil was damaged.There were no patient symptoms or complications associated with this event.Additional information received reported that no detachment attempts were made.The coil accidentally broke during procedure.There was no kink/damage observed to the pushwire.It was unknown if the coil prematurely detach in the catheter.The patient was being followed up with closely.
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
Product analysis:as found condition: the echelon-10 micro catheter, unknown guidewire, and two axium prime devices were returned for analysis within a shipping box; within their opened outer cartons; within their opened inner pouches and within their dispenser coils.The two axium prime devices were returned further within their introducer sheaths.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The axium prime pusher was found broken at 6.0cm the proximal end with the two segments retained by the release wire.The axium prime implant coil was found still attached to the pusher and found damaged within the introducer sheath (unknown guidewire) no damages or irregularities were found with the pusher or coated guidewire length.Testing/analysis: the returned coil could not be advanced out of the introducer sheath as it was found to be stuck and cannot be used for resistance testing due to the damages.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ and ¿coil resistance/stuck in catheter¿ was confirmed for the two axium prime devices as the damages found is consistent with resistance.However, the cause could not be determined, and the event could not be replicated.No resistance was observed during in-house resistance testing with the returned echelon-10 micro catheter and no damages were found with the echelon-10 that would contribute towards the resistance.The two returned axium prime implant coils were found damaged.Customer did not report any issues with advancing the coil out the sheath during preparation per ifu, therefore, it is possible the damages occurred during the attempt to push the coils into the micro catheter against the reported resistance.The pusher was found broken for one of the returned axium device, however, the release wire was not retracted far enough for the implant to detach.The axium prime coils are compatible for use with the echelon-10 micro catheter.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: 21145915
• Report Number: 2029214-2025-00120
• Device Sequence Number: 13058960
• Product Code: KRD
• UDI-Device Identifier: 00763000313708
• UDI-Public: 00763000313708
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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
• Report Date (Section B): 02/27/2025

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-2.5-4-3D-ES
• Device Catalogue Number: APB-2.5-4-3D-ES
• Device Lot Number: 228685731
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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