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

Model Number	APB-1.5-3-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that two axium coils encountered resistance in the echelon catheter hub.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the anterior communicating artery with a max diameter of 3 mm and a 2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuositywas moderate.It was reported that the axium coil was getting stuck at hub of the microcatheter and was not entering the catheter.The first coil axium 3d 3mmx6mm, went inside very easily but both the helix coil had issue entering the hub.It was reported there as coil resistance/stuck at the catheter hub.The implant coil pushed smoothly out from the introducer sheath.There was no catheter or coil damage observed.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a fubuki 6f 80cm sheath, neuron 5f guide catheter, echelon microcatheter, traxcess guidewire.Additional information received reported the procedure was completed.Additional information received reported the microcatheter was connected with 1000ml saline with pressure bag maintaining the pressure above 250.It was a continuous flush.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): two axium prime coils were returned for analysis within a shipping box; within bubble wrap; within their opened axium prime coil outer cartons; within their opened axium prime coil inner pouches and within individual dispenser tracks.The echelon-10 micro catheter used during the event was not returned for analysis.The axium prime coils were returned within their introducer sheaths.Visual inspection/damage location details: no bends or kinks were found with the axium prime coil pushwire.The axium implant coil was found to be broken and stuck within introducer sheath.The implant coil was found to be stretched and damaged.The implant coil was unable to be pushed out from introducer sheath for further analysis.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime coils could not be used for resistance testing with an in-house micro catheter due to their damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck at cath.Hub¿ could not be confirmed.Possible causes for coil resistance at catheter hub are, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush, failure to use a compatible microcatheter for delivery, and use of an improper hubbing technique (over tightening of the rhv/sheath firmly seated into hub).Improper hubbing technique could not be ruled out as a potential root cause for the event.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017" with two separate marker bands.Per axium prime coil instructions for use (ifu): ¿axium prime coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿.Therefore, the echelon-10 micro catheter was found to be compatible for use with the axium prime coils.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: 21376619
• Report Number: 2029214-2025-00417
• Device Sequence Number: 8624442
• Product Code: KRD
• UDI-Device Identifier: 00847536020955
• UDI-Public: 00847536020955
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: 09/22/2025
• Device Model Number: APB-1.5-3-HX-ES
• Device Catalogue Number: APB-1.5-3-HX-ES
• Device Lot Number: 225139119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 09/22/2022
• 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