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

Model Number	QC-16-40-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: qc-16-40-3d, item: 10, lot no: 230574119 as found condition (condition of returned device): the axium device was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.Damage location details: the pushwire was returned broken at the proximal segment; in addition, the pushwire was found to be bent at 8.7cm, bent at 15.1cm, bent at 28.4cm, bent at ,52.1cm, and bent at 64.3cm from the broken proximal end.The shield and implant coil were both broken off and not retuned.Testing/analysis (including sem reports): no testing was able to be performed as the axium device was returned damaged.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed, as the axium device was returned damaged and broken.A possible cause for device damage could be that ¿the user advanced the device against resistance¿, which was able to be confirmed as the report notes that the axium device met resistance within the microcatheter at the distal segment.No microcatheter was returned for further assessment.The only detail provided was that the microcatheter was a non-medtronic device; therefore, compatibility was unable to be determined.A few possible causes for ¿coil resistance/stuck in catheter¿ are but not limited to damage or kink to pushwire, tortuous anatomy, and incompatible catheter; however, the root cause of ¿coil resistance/stuck in catheter¿ was unable to be determined.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 patient was undergoing treatment for a saccular, unruptured left ophthalmic artery aneurysm with a max diameter of 5.4 mm and a 4.2 mm neck diameter.It was noted that the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that during the process of pushing the axium coil, the surgeon encountered resistance and could not push the coil and stuck in the distal section of the catheter.As a result, they withdrew the coil and just replaced it with another coil, and it pushed out normally.The catheter and the coil were not damaged.It was noted that the resistance was in the distal section of the catheter.The coil came out of the introducer sheath smoothly.Continuous saline flush was administered and maintained as indicated in the ifu.The catheter was not a medtronic product.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.

• 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: 22923257
• Report Number: 9617601-2025-01233
• Device Sequence Number: 15743682
• Product Code: KRD
• UDI-Device Identifier: 00847536037991
• UDI-Public: (01)00847536037991(17)280210(10)230574119
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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-16-40-3D
• Device Catalogue Number: QC-16-40-3D
• Device Lot Number: 230574119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 72 KG