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

Model Number	QC-3-8-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to treat an unruptured, saccular aneurysm located at the left posterior communicating artery, the bare axium 3d coil could not be pushed out of the protective sleeve during delivery.The aneurysm had a maximum diameter of 3.2 millimeters and a neck diameter of 2.5 millimeters.Blood flow and vessel tortuosity were described as normal.The device was never implanted and was replaced.Additional information received reported continuous saline flush was administered and maintained as indicated in the instructions for use (ifu).During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the axium device was returned for analysis within a shipping box, within a sealed paper pouch, a dispenser coil, and within an introducer sheath.Visual inspection/damage location details: the introducer sheath was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.The pushwire was found to be bent at ~6.6cm from the proximal end; in addition, the pushwire was found to be bent within the introducer sheath a ~165.4cm and bent at ~173.4cm from the distal end.The polypropylene filament was found to be broken off of the detach element, still intact with the implant coil.The axium implant coil was found to be stretched, damaged and found to be knotted outside of the introducer sheath no other anomalies were observed.Testing/analysis (including sem reports): during testing, the axium implant coil was unable to advance outside of the introducer sheath; therefore, the device was retracted from the introducer sheath without any issues.The axium implant coil tip outer diameter (od) was measured to be 0.0116¿, which was found to be within specification (specification.0112¿ +.001¿/-.0025¿).The introducer sheath id (inner diameter) was measured to be.0185¿ (0.47mm), which was found to be within specification (specification 0.47mm +0.03mm/-0.00mm).Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was able to be confirmed.The axium device was returned damaged with the implant knotted.A possible cause of ¿stuck in sheath¿ could have been caused during preparation.The report notes that ¿the introducer sheath was held vertically when the implant coil was pulled back inside during hydration¿.No damage or irregularities were reported after the preparation.The stretched found with the implant coil looks like the device was retracted against resistance, which could have happened when retracting the implant coil back in the introducer sheath during preparation.The report follows up and states ¿ the bare axium 3d coil could not be pushed out of the protective sleeve during delivery, which was able to be verified as the coil failed to advance outside of the introducer sheath during testing; however, the root cause could not be determined.A few possible causes of ¿coil resistance/stuck in sheath¿ are, but not limited to, , overtightening of rhv, and improper hubbing technique.It was noted that the patient's blood flow and vessel tortuo sity were described as normal.Additional information received reported continuous saline flush was administered and maintained as indicated in the instructions for use (ifu).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: 23294911
• Report Number: 9617601-2025-02009
• Device Sequence Number: 17359321
• Product Code: KRD
• UDI-Device Identifier: 00847536037700
• UDI-Public: (01)00847536037700(17)270430(10)228781464
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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
• Report Date (Section B): 10/14/2025

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-3-8-3D
• Device Catalogue Number: QC-3-8-3D
• Device Lot Number: 228781464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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: 67 YR
• Patient Sex: Male