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

Model Number	QC-2-4-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that during a peripheral intervention tips (transjugular intrahepatic portosystemic shunt) procedure, the surgeon used medtronic coils to assist in embolizing the fistula.When using the third coil, the backup detachment method was used to detach it.After pulling out the detachment wire, the coil did not detach from the delivery rod, which did not ensure surgical safety.A new coil was used instead and the procedure continued.The physician made 0 attempts to detach the coil with the instant detacher and there was no issue with the instant detacher.The physician did not try to detach with another instant detacher.There were 2 manual attempts at detachment via hypotube.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.The patient was undergoing surgery for peripheral intervention tips.It was noted the patient's blood flow was high and vessel tortuosity was normal.
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 was received reporting the cause of the non-detachment was not determined.Prior to coil non-detachment, no issues encountered.There was no pushwire damage observed after removal from the patient.
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): an axium coil was returned within a shipping box; within a sealed plastic biohazard pouch and within an opened axium implant coil.The axium implant coil was returned within introducer sheath.Visual inspection/damage location details: the actuator interface and break indicator were found to be intact.The axium implant pushwire was found to be bent at ~95.9cm proximal end.There did not appear to be evidence of mechanical detachment attempts.The coin was found against the lumen stop.The shield coil was found intact with the implant coil still attached.The implant coil was found to be stretched and damaged within introducer sheath with what appeared to be blood residue.Blood residue was also found beneath distal outer jacket.No other anomalies were observed.Testing/analysis (including sem reports): a manual detachment was then attempted by breaking pushwire at break indicator and retracting release wire.Release wire successfully detached implant coil.Conclusion: based on the analysis performed, the customers report of ¿non-detachment¿ was confirmed as the pusher was returned with the implant coil still attached.However, the implant coil was successfully detached manually during testing.The likely cause for the non-detachment is the bend found on the pusher or blood residue found under the distal outer jacket, causing the release wire to become stuck.The implant coil was found damaged, and the pusher was found bent.Possible causes for coil and pusher damage are patient vessel tortuosity, device was not hydrated, continuous flush was not administered during procedure, advancing device against resistance or damaged during shipment.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: 23369466
• Report Number: 9617601-2025-02200
• Device Sequence Number: 10089177
• Product Code: KRD
• UDI-Device Identifier: 00847536037625
• UDI-Public: (01)00847536037625(17)261105(10)227675848
• 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,Followup,Followup
• Report Date (Section B): 01/05/2026

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-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: 227675848
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 12/15/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/24/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2023
• 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 Age: 44 YR
• Patient Sex: Male