MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-2-3D-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	11/29/2024
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 a procedure to treat a ruptured saccular aneurysm in the internal carotid artery, a coil from the axium coil became stuck in the sheath.The aneurysm had a maximum diameter of 5 millimeters and a neck diameter of 2 millimeters, with moderate vessel tortuosity and normal blood flow.The devices, including a microcatheter (echelon) and a guidewire (avigo), were prepared as indicated in the instructions for use.The issue involved coil resistance and the coil being stuck in the sheath.The patient outcome was reported as alive with no injury.Additional information received reported the coil accidentally broke during the procedure, and no detachment attempts had been made.There was no kink/damage observed on the pushwire.
Additional Manufacturer Narrative
Product analysis #817747754:equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5 drawing(s) referenced: d00156061 rev.B; dwgs50796 rev.A as found condition: two axium prime devices were returned for analysis within a shipping box; within their opened axium prime outer cartons; within their opened axium prime inner pouches and within their introducer sheaths.It is not possible to determine which device belongs to which pli and the two will be analyzed together.Visual inspection/damage location details: (pli-10) no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the axium prime pusher.The axium prime implant coil was found damaged within the introducer sheath (figure c).No breaks were found with the implant coil.(pli-20) no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the axium prime pusher.Liquid saline was found within the sheath and on the axium prime device (figures e.F).The axium prime implant coil was found damaged within the introducer sheath (figure f).No breaks were found with the implant coil.Testing/analysis: (pli-10) the axium prime could not be advanced out of the introducer sheath as it was found stuck and was retracted out proximally.The axium prime implant coil tip od (outer diameter) was measured and found to be 0.0118¿, which is within specification (specification: 0.0108¿ +.0010¿/-.0020¿).The introducer sheath id (inner diameter) was measured to be 0.0175¿ (0.4445mm), which is within specification (0.046¿ ± 0.02¿).(pli-20) the axium prime could was advanced out of the introducer sheath with light resistance encountered.The axium prime implant coil tip od (outer diameter) was measured and found to be 0.0102¿, which is within specification (specification: 0.0108¿ +.0010¿/-.0020¿).The introducer sheath id (inner diameter) was measured to be 0.0175¿ (0.4445mm), which is within specification (0.046¿ ± 0.02¿).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed for both devices.Both implant coils were found damaged.There were no reported issues pushing the axium prime implant coils from within their introducer sheaths during hydration per ifu.Therefore, it is possible the implant coils became damaged when retracting the implants following hydration or due to improper hubbing technique (over tightening of the rhv/sheath not fully seated within the hub) subsequently causing the implant coils to become stuck.Advancing the coils against resistance would result in damage to the implants.Customer report of ¿coil separation/break¿ was not confirmed for both devices.Analysis could not determine which device was returned for the pli-10 or pli-20.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): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21063993
• Report Number: 9617601-2025-00007
• Device Sequence Number: 3409295
• Product Code: KRD
• UDI-Device Identifier: 00763000313678
• UDI-Public: 00763000313678
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 08/23/2026
• Device Model Number: APB-2-2-3D-ES
• Device Catalogue Number: APB-2-2-3D-ES
• Device Lot Number: 227220776
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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