MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-4-3D-ES
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
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
Medtronic received a report that a coil encountered resistance/was stuck in the sheath.The patient was undergoing surgery for treatment of an aneurysm of the anterior communicating artery.It was noted the patient's blood flow was normal and vessel tortuosity was severe.It was reported that while taking the first coil apb-2-4-3d, the coil got stuck at the sheath itself showing a lot of resistance and not passing into the catheter.It was noted that the coil got damaged.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information was received that there was so much resistance in the sheath itself that coil was not able to pass.While taking it back to the sheath, the coil got stuck in the microcatheter as well, hence the coil got both resistance and damaged.The cause of the resistance and damage was not determined.There were no issues that resulted in the damage that was found.A continuous saline flush was administered and maintained as indicated in the ifu.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
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 catheter resistance was in the hub of the catheter.There was no kink/damage observed to the catheter after removal.
Additional Manufacturer Narrative
3: analysis #(b)(4):equipment used: vis m-81805 203 cm ruler m-83361 pin gauges m-84081 m-84083 document used: d00154817 rev.B, 50796doc1 rev.C as found condition (condition of returned device): the axium prime implant coil was returned for analysis within a shipping box, within an opened axium prime implant coil outer carton, within an opened axium prime implant coil inner pouch, and within a dispenser coil.Damage location details: the axium prime implant coil was returned within an introducer sheath, which was found to be applied correctly, with the wavelock facing towards the proximal end of the pushwire.The introducer sheath was returned in good condition.The pushwire was found to be bent at ~7.8cm from the proximal end; however, the pushwire was found to be bent within the introducer sheath at ~5.1m from the distal end.The axium prime implant coil was found to be stretched within the introducer sheath.The axium prime implant coil was able to advance out of the introducer sheath without any issues.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime implant coil tip od (outer diameter) was measured to be.0096¿, which was found to be within specification (specification.0108¿ +.0010¿/-.0020¿).The introducer sheath id (inner diameter) was measured to be.0175¿ (0.44mm), which was found to be within specification (specification 0.46mm +0.02mm/-0.02mm).Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was unable to be confirmed, and the root cause was unable to be determined.The axium prime implant coil was returned stretched, with the pushwire was bent.The customer noted that ¿the coil got stuck at the sheath itself showing a lot of resistance.¿.This was unable to be confirmed as the coil exited the introducer sheath without any issues during testing.Advancing the implant coil against the reported resistance will lead to possible damage; therefore, it is possible the damage was caused during preparation or while the user tried to advance the coil into the catheter against resistance.The reported states, ¿the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu)¿.Possible causes of failure are but not limited to damaged implant coil, damage during preparation, overtightening of rhv, and improper hubbing technique.The customer's report of ¿coil kink/damage¿ was able to be confirmed, although the root cause was unable to be determined.This was confirmed as the implant coil was found to be stretched (damaged) within the introducer sheath.A possible cause of failure was found to be advancing the device against resi stance.The customer's report of ¿resistance/failure to resheath¿ was unable to be confirmed, and the root cause was unable to be determined.The axium prime implant coil was able to advance out of the introducer sheath and was resheathed without any issues.No patient symptoms or complications were associated with this event.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; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21375171
• Report Number: 9617601-2025-00166
• Device Sequence Number: 20969925
• Product Code: KRD
• UDI-Device Identifier: 00763000313692
• UDI-Public: 00763000313692
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2025

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-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: 229115227
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 02/13/2025; 04/11/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/24/2025; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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