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

Model Number	QC-3-6-3D
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
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 the operation was for an intracranial aneurysm embolization.The resistance during the microcatheter delivery of the spring coil was large and it was difficult to advance.When withdrawing, the spring coil was detached by itself.The microcatheter was withdrawn to remove the spring coil, and then it was replaced with a new spring coil for embolization.The operation was successfully completed.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).It was unknown if any patient symptoms or complications were associated with this event.
Additional Manufacturer Narrative
Supplemental sent for new info: b5, d9 and h6.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.The cause of the resistance and premature detachment is unknown.The resistance was in the middle section of the catheter.It was unknown if the coil came out of the introducer sheath smoothly.A continuous saline flush administered and maintained as indicated in the ifu.After removal the coil was kinked.It was unknown if the catheter or the pushwire were damaged after removal.There were no detachment attempts (instant detacher or manual method) made.
Additional Manufacturer Narrative
Product analysis as found condition: the axium device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and within an introducer sheath.The unknown micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.Two breaks were found near the break indicator (figures d e).This is indicative of detachment attempts at these locations.The pusher was found bent between ~91.2cm and ~103.0cm from the proximal end of the distal segment.The coin was found fully retracted out of the lumen stop.The shield coil was found stretched (figure g).The implant coil was already detached and not returned for analysis.Testing/analysis: the axium device could not be used for resistance testing with an in-house micro catheter due to the damaged condition.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" could not be confirmed.Although the implant was found detached, the pusher was found broken twice near the break indicator and the release wire/coin were retracted from within the pusher/lumen stop; detaching the implant coil as expected by the detachment subassemblies.Customer reported they did not attempt to detach the device using an instant detacher or by manual method.The customer report of ¿coil resistance/stuck in catheter¿ was likely to have occurred as the damages found is consistent with resistance.The shield coil was found stretched and the pusher was found bent.It is likely these damages occurred due to advancing/retracting against the reported resistance.Possible contributors to the shield coil stretching include, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, damaged catheter, or incompatible catheter.Customer reported devices were prepared per ifu and continuous flush was administered.The likely cause could not be determined.As the unknown micro catheter and implant coil (including the detach element) were not returned for analysis, any contribution of the micro catheter, implant coil and detach element to the premature detachment and resistance could not be determined.The customer report of ¿coil kink/damage¿ could not be confirmed as the implant was not returned.However, it is possible it has occurred due to other damages found and the reported resistance.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 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: 22506116
• Report Number: 9617601-2025-00630
• Device Sequence Number: 18305877
• Product Code: KRD
• UDI-Device Identifier: 00847536037694
• UDI-Public: (01)00847536037694(17)270903(10)229539066
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 09/12/2025

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: QC-3-6-3D
• Device Catalogue Number: QC-3-6-3D
• Device Lot Number: 229539066
• 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: 07/13/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 08/20/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/13/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 57 KG